12-Week Study in Adult Subjects With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dey
ClinicalTrials.gov Identifier:
NCT01516073
First received: January 13, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone Propionate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dey:

Primary Outcome Measures:
  • FEV1 (Forced Expiry Volume in 1 second) [ Time Frame: Change in FEV1 at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak Expiratory Flow Rate (PEFR) [ Time Frame: PEFR at Week 12 ] [ Designated as safety issue: No ]

Enrollment: 629
Study Start Date: March 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluticasone Propionate (FP) - arm 1
FP BID (twice daily)
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable
Experimental: Fluticasone propionate (FP) - arm 2
FP BID
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable
Experimental: Fluticasone Propionate (FP) - arm 3
FP BID
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable
Experimental: FLuticasone Propionate (FP) - Arm 4
FP BID
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable
Experimental: Fluticasone Propionate (FP) - Arm 5
FP BID
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable
Placebo Comparator: Placebo - Arm 6
Placebo inhalation solution 2mL
Drug: Fluticasone Propionate
FP BID for 12 weeks
Other Name: No other names are applicable

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516073

Locations
United States, South Carolina
Greenville Pharmaceutical research, Inc.
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Dey
Investigators
Study Director: Imtiaz Chaudry Dey Pharma, L.P.
  More Information

No publications provided

Responsible Party: Dey
ClinicalTrials.gov Identifier: NCT01516073     History of Changes
Other Study ID Numbers: 191-091
Study First Received: January 13, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dey:
partially controlled
uncontrolled

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014