A 12-Week Study in Adult Subjects With Asthma

November 24, 2014 updated by: Dey

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 rescue medication usage.

Study Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • CU Pharmaceutical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluticasone Propionate (FP) - arm 1
FP BID (twice daily)
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable
Experimental: Fluticasone propionate (FP) - arm 2
FP BID
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable
Experimental: Fluticasone Propionate (FP) - arm 3
FP BID
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable
Experimental: FLuticasone Propionate (FP) - Arm 4
FP BID
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable
Experimental: Fluticasone Propionate (FP) - Arm 5
FP BID
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable
Placebo Comparator: Placebo - Arm 6
Placebo inhalation solution
Drug: Fluticasone Propionate (FP)
FP Inhalation BID
Other Names:
  • No other names applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 (Forced Expiry Volume in 1 second)
Time Frame: FEV1 at Week 12
FEV1 at Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak Expiratory Flow Rate (PEFR)
Time Frame: PEFR at Week 12
PEFR at Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dey

Investigators

  • Study Director: Imtiaz Chaudry, Dey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

January 13, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 191-092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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