Clinical trial NCT01479621: A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids
Official title: A 12-Week Dose-ranging Study to Evaluate the Efficacy and Safety of Fluticasone Propionate DPI Administered Twice Daily Compared With Placebo in Adolescent and Adult Subjects With Persistent Asthma Uncontrolled on Non-steroidal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Dose Ranging
Fluticasone Propionate
Dry Powder Inhaler (DPI)
Non-steroidal
Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2011-11-24
Enrollment: 909
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent/assent signed and dated by the subject and/or parent /legal guardian before conducting any study related procedure.
2. Male or female 12 years and older, as of the Screening Visit. Male or female 18 years and older, as of the Screening Visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adults only.
3. General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the study.
4. Asthma Diagnosis: Asthma as defined by the National Institutes of Health (NIH).
5. Severity of Disease: A best forced expiratory volume in one second (FEV1) of 40%-85% of the predicted normal value during the Screening Visit. NHANES III predicted values will be used for subjects aged ≥12 years and adjustments to predicted values will be made for African American subjects.
6. Reversibility of Disease: Demonstrated a ≥15% reversibility of FEV1 within 30 minutes following 2 inhalations of albuterol/salbutamol inhalation aerosol (if required, spacers are permitted for reversibility testing only) at the Screening Visit. If a subject fails to demonstrate an increase in FEV1 ≥15%, then the subject is not eligible for the study and will not be allowed to re-screen.
7. Current Asthma Therapy: Subjects must be on a short-acting β2-agonist alone or a non-corticosteroid maintenance medication (with or without a short-acting β2-agonist) for ≥ 3 months preceding the Screening Visit. Subjects must not have used an inhaled corticosteroid for at least 6 weeks preceding the Screening Visit.

   Exception: Based upon the investigator's judgment that there is no inherent harm in changing the subject's current ICS therapy and the subject provides consent, subjects on low dose ICS (100mcg Fp BID or equivalent) may be switched to a short-acting β2 agonist alone at a Pre-screening Visit. The subject will be required to return to the clinic to complete the Screening Visit once the 2-week washout period has been completed.
8. Short-Acting β2-Agonists: All subjects must be able to replace their current short-acting β2-agonists with albuterol/salbutamol inhalation aerosol at the Screening Visit for use as needed for the duration of the study. The use of spacer devices with the metered dose inhaler (MDI) will not be allowed during the study with exception of its use during reversibility testing at the Screening Visit. Nebulized albuterol/salbutamol will not be allowed at any time during the study. Subjects must be able to withhold all inhaled short-acting beta sympathomimetic bronchodilators for at least 6 hours prior to all study visits.
9. If female, is currently not pregnant, breast feeding, or attempting to become pregnant, has a negative serum pregnancy test, and is of

   1. Non-childbearing potential, defined as:

      * Before menarche or \> or =1 year post-menopausal or
      * Surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or
      * Congenital sterility or
      * Diagnosed as infertile and not undergoing treatment to reverse infertility or is of
   2. Child-bearing potential, willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study:

      * Systemic contraception used for \> or = 1 month prior to screening, including birth control pills, transdermal patch (Ortho Evra®), vaginal ring (NuvaRing®), levonorgesterel (Norplant®), or injectable progesterone (Depo-Provera®) or
      * Double barrier methods (condoms, cervical cap, diaphragm, and vaginal contraceptive film with spermicide) or
      * Intrauterine device (IUD) or is of
   3. Child-bearing potential and not sexually active, willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study, in the event the subject becomes sexually active.
10. Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (visits, record-keeping, etc).

Exclusion Criteria:

1. History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
2. Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks prior to the Screening Visit. In addition, the subject must be excluded if such infection occurs between the Screening Visit and the Randomization Visit.
3. Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit. A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit.

   Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol/salbutamol HFA MDI and/or the subject's regular non-corticosteroid maintenance treatment. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization, a change in the subject's regular non-corticosteroid maintenance treatment, or the addition of other asthma medications.
4. Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
5. Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal (e.g., poorly-controlled peptic ulcer, GERD), or pulmonary (e.g., chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
6. Have any of the following conditions that, in the judgment of the investigator, might cause participation in this study to be detrimental to the subject, including, but not limited to:

   * Current malignancy excluding basal cell carcinoma; History of malignancy is acceptable only if the subject has been in remission for one year prior to the Screening Visit. (Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months prior to the Screening Visit)
   * Current or untreated tuberculosis; History of tuberculosis is acceptable only if a subject has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years • Uncontrolled hypertension (systolic BP ≥160 or diastolic BP \>100)
   * Stroke within 3 months prior to the Screening Visit
   * Immunologic compromise
7. History of a positive test for HIV, hepatitis B or hepatitis C infection.
8. Clinical visual evidence of oral candidiasis at the Screening Visit.
9. History of any adverse reaction, including immediate or delayed hypersensitivity to any β2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the dry powder inhalers (Spiromax or Diskus) used in the study (i.e., lactose).
10. History of severe allergy to milk protein.
11. Use of systemic, oral or depot corticosteroids within 12 weeks prior to the Screening Visit

    * Use of topical corticosteroids (≤1% hydrocortisone cream) for dermatological disease is permitted
    * Use of intranasal corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit and throughout the study is permitted
12. Use of immunosuppressive medications within 4 weeks prior to the Screening Visit and during the study.
13. Immunotherapy at a stable dose for at least 90 days prior to the Screening Visit and throughout the study for the treatment of allergies is permitted.
14. Use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 4 weeks prior to the Screening Visit.
15. History of alcohol or drug abuse within two years preceding the Screening Visit.
16. Current smoker or a smoking history of 10 pack years or more (a pack year is defined as smoking 1 pack of cigarettes/day for 1 year). A subject may not have used tobacco products within the past one year (e.g., cigarettes, cigars, chewing tobacco, or pipe tobacco).
17. Study participation by clinical investigator site employees and/or their immediate relatives.
18. Study participation by more than one subject from the same household at the same time. However, after the study completion or discontinuation by one subject another subject from the same household may be screened.
19. Participation in any investigational drug study within the 30 days (starting at the final follow-up visit) preceding the Screening Visit or planned participation in another investigational drug study at any time during this study.
20. Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject's last study related visit (for eligible subjects only - if applicable). Eligible female subjects unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded.

Primary outcomes:
measure: Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period
timeFrame: Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)
Secondary outcomes:
measure: Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
timeFrame: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
measure: Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period
timeFrame: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
measure: Change From Baseline in the Percentage of Rescue-Free 24-hour Periods During the 12-Week Treatment Period
timeFrame: Baseline (Days -7 to -1), During Study (Days 1-84)
measure: Kaplan-Meier Estimate of Probability of Remaining in the Study at Week 12
timeFrame: Day 1 to Day 84
measure: Area Under The Curve From Time 0 Until The Last Measurable Concentration (AUC0-t) of Fp
timeFrame: Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
measure: Maximum Observed Plasma Concentration (Cmax) of Fp
timeFrame: Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
measure: Time of Maximum Concentration (Tmax) of Fp
timeFrame: Day 1: predose (within 10 minutes of treatment administration), and 5, 10, 15, 30, and 45 minutes, 1 hour, 1 hour 15 minutes, 1 hour 30 minutes, and 2, 4, 8, and 12 hours postdose
measure: Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
timeFrame: Day 1 -84
measure: Oropharyngeal Exam Findings at Each Study Visit
timeFrame: Screening (week -3 to -2), Baseline (Week 0), Weeks 1, 2, 4, 8, 12
Other outcomes:
measure: Change From Baseline In Trough (Morning Predose And Pre-Rescue Bronchodilator) Forced Expiratory Volume In 1 Second (FEV1) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
timeFrame: Baseline (Day 1, pre-dose), During Study (Days 7, 14, 28, 56 and 84 pre-dose)
measure: Change From Baseline In Weekly Average Of Daily Trough (Predose And Pre-Rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
timeFrame: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
measure: Change From Baseline In Weekly Average Of Daily Evening Peak Expiratory Flow (PEF) Over The 12-Week Treatment Period Inclusive of Flovent Diskus Data
timeFrame: Baseline (Days -7 to 1, am pre-dose), During Study (Days 2-84 am pre-dose)
Locations:
city: Homewood
country: United States
facility: Teva Investigational Site 10165
state: Alabama
city: Goodyear
country: United States
facility: Teva Investigational Site 11142
state: Arizona
city: Scottsdale
country: United States
facility: Teva Investigational Site 10104
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 11149
state: Arkansas
city: Bakersfield
country: United States
facility: Teva Investigational Site 10173
state: California
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10163
state: California
city: Encinitas
country: United States
facility: Teva Investigational Site 10156
state: California
city: Fountain Valley
country: United States
facility: Teva Investigational Site 11101
state: California
city: Fresno
country: United States
facility: Teva Investigational Site 11111
state: California
city: Granada Hills
country: United States
facility: Teva Investigational Site 10151
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10157
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10176
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 10147
state: California
city: Napa
country: United States
facility: Teva Investigational Site 11110
state: California
city: Newport Beach
country: United States
facility: Teva Investigational Site 10136
state: California
city: North Hollywood
country: United States
facility: Teva Investigational Site 11122
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10140
state: California
city: Palmdale
country: United States
facility: Teva Investigational Site 10197
state: California
city: Redwood City
country: United States
facility: Teva Investigational Site 10185
state: California
city: Riverside
country: United States
facility: Teva Investigational Site 10143
state: California
city: Roseville
country: United States
facility: Teva Investigational Site 11137
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10130
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10182
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 10179
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 10106
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 10129
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 10145
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10172
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 10133
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 10154
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 11146
state: Colorado
city: Wheat Ridge
country: United States
facility: Teva Investigational Site 10128
state: Colorado
city: Waterbury
country: United States
facility: Teva Investigational Site 10196
state: Connecticut
city: Boynton Beach
country: United States
facility: Teva Investigational Site 10191
state: Florida
city: Brandon
country: United States
facility: Teva Investigational Site 11127
state: Florida
city: Clearwater
country: United States
facility: Teva Investigational Site 11118
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 11141
state: Florida
city: Kissimmee
country: United States
facility: Teva Investigational Site 11140
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10137
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10153
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 11120
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 11128
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 11132
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 11145
state: Florida
city: Ocala
country: United States
facility: Teva Investigational Site 10171
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 10178
state: Florida
city: South Miami
country: United States
facility: Teva Investigational Site 11103
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 10161
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 10139
state: Florida
city: Albany
country: United States
facility: Teva Investigational Site 11114
state: Georgia
city: Columbus
country: United States
facility: Teva Investigational Site 10111
state: Georgia
city: Columbus
country: United States
facility: Teva Investigational Site 11124
state: Georgia
city: Gainesville
country: United States
facility: Teva Investigational Site 10180
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Investigational Site 10168
state: Georgia
city: Idaho Falls
country: United States
facility: Teva Investigational Site 11109
state: Idaho
city: Meridian
country: United States
facility: Teva Investigational Site 10116
state: Idaho
city: South Bend
country: United States
facility: Teva Investigational Site 10127
state: Indiana
city: Iowa City
country: United States
facility: Teva Investigational Site 10184
state: Iowa
city: Metairie
country: United States
facility: Teva Investigational Site 10113
state: Louisiana
city: Bangor
country: United States
facility: Teva Investigational Site 10164
state: Maine
city: Bethesda
country: United States
facility: Teva Investigational Site 10158
state: Maryland
city: Largo
country: United States
facility: Teva Investigational Site 10110
state: Maryland
city: Wheaton
country: United States
facility: Teva Investigational Site 10177
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10138
state: Massachusetts
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10146
state: Massachusetts
city: Minneapolis
country: United States
facility: Teva Investigational Site 10131
state: Minnesota
city: Saint Louis
country: United States
facility: Teva Investigational Site 10175
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 10189
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 11147
state: Missouri
city: Bellevue
country: United States
facility: Teva Investigational Site 10118
state: Nebraska
city: Omaha
country: United States
facility: Teva Investigational Site 10150
state: Nebraska
city: Omaha
country: United States
facility: Teva Investigational Site 11144
state: Nebraska
city: Henderson
country: United States
facility: Teva Investigational Site 11136
state: Nevada
city: Bricktown
country: United States
facility: Teva Investigational Site 10114
state: New Jersey
city: Cherry Hill
country: United States
facility: Teva Investigational Site 10193
state: New Jersey
city: Hillsborough
country: United States
facility: Teva Investigational Site 10101
state: New Jersey
city: Skillman
country: United States
facility: Teva Investigational Site 10155
state: New Jersey
city: West Orange
country: United States
facility: Teva Investigational Site 10188
state: New Jersey
city: Albuquerque
country: United States
facility: Teva Investigational Site 11113
state: New Mexico
city: Brooklyn
country: United States
facility: Teva Investigational Site 10187
state: New York
city: New York
country: United States
facility: Teva Investigational Site 10120
state: New York
city: Newburgh
country: United States
facility: Teva Investigational Site 10190
state: New York
city: North Syracuse
country: United States
facility: Teva Investigational Site 10167
state: New York
city: Rochester
country: United States
facility: Teva Investigational Site 10112
state: New York
city: High Point
country: United States
facility: Teva Investigational Site 10105
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 10122
state: North Carolina
city: Canton
country: United States
facility: Teva Investigational Site 10194
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10107
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10123
state: Ohio
city: Columbus
country: United States
facility: Teva Investigational Site 10144
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 11135
state: Ohio
city: Middleburg Heights
country: United States
facility: Teva Investigational Site 11115
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10160
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10174
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10198
state: Oklahoma
city: Ashland
country: United States
facility: Teva Investigational Site 11108
state: Oregon
city: Eugene
country: United States
facility: Teva Investigational Site 10132
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10135
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10142
state: Oregon
city: Normal
country: United States
facility: Teva Investigational Site 11104
state: Pennsylvania
city: Philadelphia
country: United States
facility: Teva Investigational Site 10183
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 10166
state: Pennsylvania
city: Upland
country: United States
facility: Teva Investigational Site 10121
state: Pennsylvania
city: East Providence
country: United States
facility: Teva Investigational Site 11119
state: Rhode Island
city: Lincoln
country: United States
facility: Teva Investigational Site 10181
state: Rhode Island
city: Providence
country: United States
facility: Teva Investigational Site 10162
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 10126
state: South Carolina
city: Charleston
country: United States
facility: Teva Investigational Site 10149
state: South Carolina
city: Orangeburg
country: United States
facility: Teva Investigational Site 10199
state: South Carolina
city: Spartanburg
country: United States
facility: Teva Investigational Site 11131
state: South Carolina
city: Boerne
country: United States
facility: Teva Investigational Site 10119
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10141
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10192
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 10148
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10115
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 11133
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 11134
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 10103
state: Texas
city: Layton
country: United States
facility: Teva Investigational Site 11143
state: Utah
city: Provo
country: United States
facility: Teva Investigational Site 10195
state: Utah
city: South Burlington
country: United States
facility: Teva Investigational Site 10134
state: Vermont
city: Burke
country: United States
facility: Teva Investigational Site 10159
state: Virginia
city: Fairfax
country: United States
facility: Teva Investigational Site 10102
state: Virginia
city: Manassas
country: United States
facility: Teva Investigational Site 11105
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 10108
state: Virginia
city: Spokane
country: United States
facility: Teva Investigational Site 10124
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 11117
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 11125
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 10170
state: Wisconsin
city: Burgas
country: Bulgaria
facility: Teva Investigational Site 59107
city: Lovech
country: Bulgaria
facility: Teva Investigational Site 59103
city: Pleven
country: Bulgaria
facility: Teva Investigational Site 59106
city: Ruse
country: Bulgaria
facility: Teva Investigational Site 59104
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59101
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59102
city: Sofia
country: Bulgaria
facility: Teva Investigational Site 59105
city: Split
country: Croatia
facility: Teva Investigational Site 85105
city: Zagreb
country: Croatia
facility: Teva Investigational Site 85102
city: Zagreb
country: Croatia
facility: Teva Investigational Site 85103
city: Zagreb
country: Croatia
facility: Teva Investigational Site 85104
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 36107
city: Budapest
country: Hungary
facility: Teva Investigational Site 36104
city: Budapest
country: Hungary
facility: Teva Investigational Site 36105
city: Csoma
country: Hungary
facility: Teva Investigational Site 36113
city: Miskolc
country: Hungary
facility: Teva Investigational Site 36103
city: Mosdos
country: Hungary
facility: Teva Investigational Site 36108
city: Nyiregyhaza
country: Hungary
facility: Teva Investigational Site 36102
city: Szeged
country: Hungary
facility: Teva Investigational Site 36106
city: Szeged
country: Hungary
facility: Teva Investigational Site 36109
city: Szombathely
country: Hungary
facility: Teva Investigational Site 36101
city: Tatabanya
country: Hungary
facility: Teva Investigational Site 36111
city: Ashkelon
country: Israel
facility: Teva Investigational Site 72111
city: Haifa
country: Israel
facility: Teva Investigational Site 72101
city: Jerusalem
country: Israel
facility: Teva Investigational Site 72102
city: Jerusalem
country: Israel
facility: Teva Investigational Site 72104
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 72109
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 72106
city: Ramat-Gan
country: Israel
facility: Teva Investigational Site 72107
city: Rehovot
country: Israel
facility: Teva Investigational Site 72103
city: Tel Aviv
country: Israel
facility: Teva Investigational Site 72110
city: Tel-Aviv
country: Israel
facility: Teva Investigational Site 72108
city: Bialystok
country: Poland
facility: Teva Investigational Site 48107
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 48105
city: Grodzisk Mazowiecki
country: Poland
facility: Teva Investigational Site 48106
city: Lodz
country: Poland
facility: Teva Investigational Site 48101
city: Poznan
country: Poland
facility: Teva Investigational Site 48108
city: Tarnow
country: Poland
facility: Teva Investigational Site 48103
city: Wroclaw
country: Poland
facility: Teva Investigational Site 48104
city: Belgrade
country: Serbia
facility: Teva Investigational Site 81101
city: Belgrade
country: Serbia
facility: Teva Investigational Site 81102
city: Badalona
country: Spain
facility: Teva Investigational Site 34101
city: Barcelona
country: Spain
facility: Teva Investigational Site 34102
city: Salt
country: Spain
facility: Teva Investigational Site 34103
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 80101
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 80113
city: Donetsk
country: Ukraine
facility: Teva Investigational Site 80111
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 80103
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 80117
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80104
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80105
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80106
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80107
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80108
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 80109
city: Odesa
country: Ukraine
facility: Teva Investigational Site 80114
city: Ternopil
country: Ukraine
facility: Teva Investigational Site 80118
city: Vinnytsya
country: Ukraine
facility: Teva Investigational Site 80112
city: Yalta
country: Ukraine
facility: Teva Investigational Site 80115
city: Zaporizhzhia
country: Ukraine
facility: Teva Investigational Site 80110
Study officials:
References: