Clinical trial NCT01698320: Safety Study of Albuterol Spiromax® in Subjects With Asthma
Official title: A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2012-10-03
Enrollment: 364
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: The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.


Eligibility criteria: Inclusion Criteria:

* Written informed consent and HIPAA signed and dated by the subject or written informed assent signed and dated both by the subject and/or parent/caregiver/legal guardian before conducting any study related procedure.
* Males or females with asthma ages 12 years or older at screening.
* Documented history of persistent asthma and current use of an MDI containing any short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at least once/week over the 4-weeks prior to screening. The asthma diagnosis must be consistent with the diagnosis of asthma as per the National Asthma Education and Prevention Program.
* If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the screening visit and throughout the duration of the study), and is of Non-childbearing potential, defined as:

  * ≥1 year post-menopausal or
  * Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy) or is of
  * Childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control
* General good health in the opinion of the investigator as indicated by medical history, physical examination, laboratory tests (hematology, serum chemistry and urinalysis) assessed as either normal or abnormal not clinically significant (NCS) per the principal investigator, as well as a 12-lead ECG interpreted as either "Normal" or "Abnormal NCS" as determined by the central cardiologist. Subjects must also be free of any clinically significant, uncontrolled concomitant conditions other than asthma that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the trial.
* Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, and being compliant with all study requirements (visits, record-keeping, etc).
* Non-smoker for at least one year prior to the screening visit and a maximum pack-year (PY) smoking history of 10 years.
* Able to demonstrate proper inhaler technique with study inhaler.

Exclusion Criteria:

* 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.
* Participation in any investigational drug trial within 30 days preceding the screening visit or planned participation in another investigational drug trial at any time during this trial.
* A known hypersensitivity to albuterol or any of the excipients in the formulations.
* History of severe milk protein allergy
* History of an upper or lower respiratory tract infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved at least 1 week prior to the SV.
* History of alcohol or drug abuse within two years preceding the SV.
* Use of any protocol prohibited concomitant medications for asthma (any oral β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications including treatment with β2-adrenergic receptor antagonists and non-selective β-receptor blocking agents such as β-blocking anti-hypertensive products (administered by any route), MAO inhibitors, and/or tricyclic antidepressants. (Subject's own MDI short-acting β-agonist rescue inhaler should be used until the start of the Run-In period when a study rescue inhaler is provided.)
* Inability or unwillingness to comply with the protocol requirements.
* History of life-threatening asthma \[defined here as an asthma episode requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures.\]
* Any asthma exacerbation within 3 months of the SV requiring oral or systemic corticosteroids or any hospitalization for asthma within 6 months of the SV.

Note: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol or the subject's regular asthma maintenance therapy. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization or a change in subject's regular asthma maintenance treatment. A subject does not need to be withdrawn from the study due to an asthma exacerbation unless hospitalization is required or unless the principal investigator believes it is in the subjects' best interest to withdraw from the study.

* Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the exception of the ABS-AS-306 study.
* Study participation by clinical investigator site employees and/or their immediate relatives.
* Study participation by related or non-related individuals living in the same household, i.e. only one subject per household may participate in the study.
* Any clinically significant endocrine, hematological, hepatic, renal, gastrointestinal, neurological, cardiac, metabolic, immunological, any non-asthmatic acute or chronic pulmonary condition (including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis), and malignancy other than basal cell carcinoma. Significant is defined for this protocol as any condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the safety analyses.
* Any medical or psychological condition that in the investigator's opinion should preclude enrollment.

Primary outcomes:
measure: Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)
timeFrame: Day 1 to Week 12
measure: Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)
timeFrame: Weeks 13-52
measure: Electrocardiogram (ECG) Results At Weeks 0, 12, and 52
timeFrame: Weeks 0 (screening visit), 12, and 52
measure: Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52
timeFrame: Week 0, Week 12 and Week 52
measure: Change From Baseline in Pulse Measurements to Week 12 and Week 52
timeFrame: Week 0, Week 12 and Week 52
measure: Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52
timeFrame: Weeks 0, 12 and 52
Secondary outcomes:
Other outcomes:
measure: Composite Measurement of Device Ruggedness From Baseline to Week 52
timeFrame: Baseline to Week 52
measure: Device Invitro Evaluations to Week 52
timeFrame: Baseline to Week 52
measure: Daily AM Peak Expiratory Flow (PEF) to Week 52
timeFrame: Baseline to Week 52
Locations:
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10169
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10157
state: California
city: Denver
country: United States
facility: Teva Investigational Site 10148
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 10159
state: Colorado
city: Miami
country: United States
facility: Teva Investigational Site 10158
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10168
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 10154
state: Georgia
city: Louisville
country: United States
facility: Teva Investigational Site 10161
state: Kentucky
city: Bethesda
country: United States
facility: Teva Investigational Site 10162
state: Maryland
city: Wheaton
country: United States
facility: Teva Investigational Site 10166
state: Maryland
city: Minneapolis
country: United States
facility: Teva Investigational Site 10151
state: Minnesota
city: Plymouth
country: United States
facility: Teva Investigational Site 10142
state: Minnesota
city: St. Louis
country: United States
facility: Teva Investigational Site 10152
state: Missouri
city: Bellevue
country: United States
facility: Teva Investigational Site 10146
state: Nebraska
city: Skillman
country: United States
facility: Teva Investigational Site 10160
state: New Jersey
city: Rochester
country: United States
facility: Teva Investigational Site 10144
state: New York
city: High Point
country: United States
facility: Teva Investigational Site 10141
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 10153
state: North Carolina
city: Canton
country: United States
facility: Teva Investigational Site 10147
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10143
state: Ohio
city: Sylvania
country: United States
facility: Teva Investigational Site 10167
state: Ohio
city: Eugene
country: United States
facility: Teva Investigational Site 10150
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10156
state: Oregon
city: El Paso
country: United States
facility: Teva Investigational Site 10155
state: Texas
city: New Braunfels
country: United States
facility: Teva Investigational Site 10149
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10145
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10170
state: Texas
city: Burke
country: United States
facility: Teva Investigational Site 10163
state: Virginia
city: Seattle
country: United States
facility: Teva Investigational Site 10165
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 10164
state: Wisconsin
Study officials:
References:
citation: Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.