12-Week Study in Adult Subjects With Asthma

NCT01516073 | Completed Phase 2

• 1 other identifier: 191-091
• Study Type: interventional
• Target: 629
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

partially controlled; uncontrolled

Outcome Measures

Primary Outcomes (1)

• FEV1 (Forced Expiry Volume in 1 second)

  Change in FEV1 at Week 12

Secondary Outcomes (1)

• Peak Expiratory Flow Rate (PEFR)

  PEFR at Week 12

Study Arms (6)

Fluticasone Propionate (FP) - arm 1

EXPERIMENTAL

FP BID (twice daily)

Drug: Fluticasone Propionate

Fluticasone propionate (FP) - arm 2

EXPERIMENTAL

FP BID

Drug: Fluticasone Propionate

Fluticasone Propionate (FP) - arm 3

EXPERIMENTAL

FP BID

Drug: Fluticasone Propionate

FLuticasone Propionate (FP) - Arm 4

EXPERIMENTAL

FP BID

Drug: Fluticasone Propionate

Fluticasone Propionate (FP) - Arm 5

EXPERIMENTAL

FP BID

Drug: Fluticasone Propionate

Placebo - Arm 6

PLACEBO COMPARATOR

Placebo inhalation solution 2mL

Drug: Fluticasone Propionate

Interventions

Fluticasone Propionate DRUG

FP BID for 12 weeks

Also known as: No other names are applicable

FLuticasone Propionate (FP) - Arm 4; Fluticasone Propionate (FP) - Arm 5; Fluticasone Propionate (FP) - arm 1; Fluticasone Propionate (FP) - arm 3; Fluticasone propionate (FP) - arm 2; Placebo - Arm 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A signed and dated written informed consent form prior to the conduct of any study procedures
• Males and females between 18 and 60 years old.
• Non-smoker for at least 1 year prior to Visit 1, with a smoking history of no more than 10 pack-years.
• Ability to understand and comply with the protocol requirements (including completion of daily PEFR, PFT and ACQ), instructions and protocol-stated restrictions.
• 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.
• Agreement by subject to abide by the study protocol and its restrictions.

You may not qualify if:

• 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).
• An upper or lower respiratory tract infection within 4 weeks of Visit 1 and prior to Visit 2
• A history of hypersensitivity to the study drug or its components, including albuterol as rescue medication.
• History of illegal drug or alcohol abuse within the past 5 years.
• Pregnant or lactating women.
• Use of an investigational drug or device within 30 days prior to screening.

Sponsors & Collaborators

• Dey: lead

Study Sites (1)

Greenville Pharmaceutical research, Inc.

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Imtiaz Chaudry

  Dey Pharma, L.P.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: January 24, 2012
• Study Start: March 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: December 11, 2014

Record last verified: 2014-11

Locations

US (1)