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A 12-Week Study in Adult Subjects With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01516086
First received: January 13, 2012
Last updated: January 7, 2014
Last verified: January 2014

January 13, 2012
January 7, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
FEV1 (Forced Expiry Volume in 1 second) [ Time Frame: FEV1 at Week 12 ] [ Designated as safety issue: No ]
FEV1 [ Time Frame: FEV1 at Week 12 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01516086 on ClinicalTrials.gov Archive Site
Peak Expiratory Flow Rate (PEFR) [ Time Frame: PEFR at Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A 12-Week Study in Adult Subjects With Asthma
A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects With Partly Controlled and Uncontrolled Asthma

This will be a multi-center, randomized, placebo controlled parallel-group study to Replicate Efficacy of Nebulized Fluticasone Propionate (FP) in Adult Subjects with Partly Controlled and Uncontrolled Asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.

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 rescue medication usage.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Name: No other names applicable
  • Experimental: Fluticasone Propionate (FP) - arm 1
    FP BID (twice daily)
    Intervention: Drug: Fluticasone Propionate (FP)
  • Experimental: Fluticasone propionate (FP) - arm 2
    FP BID
    Intervention: Drug: Fluticasone Propionate (FP)
  • Experimental: Fluticasone Propionate (FP) - arm 3
    FP BID
    Intervention: Drug: Fluticasone Propionate (FP)
  • Experimental: FLuticasone Propionate (FP) - Arm 4
    FP BID
    Intervention: Drug: Fluticasone Propionate (FP)
  • Experimental: Fluticasone Propionate (FP) - Arm 5
    FP BID
    Intervention: Drug: Fluticasone Propionate (FP)
  • Placebo Comparator: Placebo - Arm 6
    Placebo inhalation solution
    Intervention: Drug: Fluticasone Propionate (FP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
498
November 2013
November 2013   (final data collection date for primary outcome measure)

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 (e.g., 1 pack [20 cigarettes] per day for 10 years).

6.Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.

7.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.

    8.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. An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
  3. A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
  4. History of illegal drug or alcohol abuse within the past 5 years.
  5. Pregnant or lactating women.
  6. Use of > 8 inhalations per day of SABA on any two consecutive days from screening to randomization (Visits 1 and 2).
  7. Use of an investigational drug or device within 30 days prior to screening
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516086
191-092
No
Dey
Dey
Not Provided
Study Director: Imtiaz Chaudry Dey
Dey
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP