Clinical trial NCT01516073: 12-Week Study in Adult Subjects With Asthma
Official title: A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Nebulized Fluticasone Propionate (FP) Dose Response in Adult Subjects With Partly Controlled and Uncontrolled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: partially controlled
uncontrolled
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2012-01-24
Enrollment: 629
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled and uncontrolled asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.

Detailed description: The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ), nighttime awakenings and reduce medication usage.

Eligibility criteria: Inclusion Criteria:

1. A signed and dated written informed consent form prior to the conduct of any study procedures
2. Males and females between 18 and 60 years old.
3. Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years.
4. Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.
5. Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit. WOCBP include: any female who has experienced menarche and is not post-menopausal (defined as amenorrhea for at least 12 consecutive months), or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP.

   WOCBP must agree to avoid becoming pregnant for the duration of the study by using adequate contraception at study entry and throughout the trial. Examples of adequate contraception include the following:
   * Norplant
   * Medroxyprogesterone acetate injection
   * Oral contraception
   * Double-barrier method (e.g., condom and spermicide)
   * Abstinence, with one of the above WOCBP will be advised to notify the Investigator of any changes in their pregnancy status or any change in contraceptive use.
6. Agreement by subject to abide by the study protocol and its restrictions.

Exclusion Criteria:

1. Past or present disease, excluding asthma, which as judged by the investigator, may place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives These diseases include, but are not limited to cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, diabetes type I or uncontrolled diabetes, type II, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to chronic bronchitis, emphysema, bronchiectasis, COPD, eosinophilic bronchitis or pulmonary fibrosis).
2. Clinically significant abnormalities in safety laboratory analysis at screening (Visit 1) and deemed exclusionary by the Investigator.
3. An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
4. A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
5. History of illegal drug or alcohol abuse within the past 5 years.
6. Pregnant or lactating women.
7. Use of an investigational drug or device within 30 days prior to screening.

Primary outcomes:
measure: FEV1 (Forced Expiry Volume in 1 second)
timeFrame: Change in FEV1 at Week 12
Secondary outcomes:
measure: Peak Expiratory Flow Rate (PEFR)
timeFrame: PEFR at Week 12
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Greenville Pharmaceutical research, Inc.
state: South Carolina
Study officials:
affiliation: Dey Pharma, L.P.
name: Imtiaz Chaudry
role: STUDY_DIRECTOR
References: