12-Week Study in Adult Subjects With Asthma

Dey Pharma

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Fluticasone Propionate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01516073

191-091

Details and patient eligibility

About

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.

Full 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.

Enrollment: 629 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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629 participants in 6 patient groups, including a placebo group

Fluticasone Propionate (FP) - arm 1

Experimental group

Description:

FP BID (twice daily)

Treatment:

Drug: Fluticasone Propionate

Fluticasone propionate (FP) - arm 2

Experimental group

Description:

FP BID

Treatment:

Drug: Fluticasone Propionate

Fluticasone Propionate (FP) - arm 3

Experimental group

Description:

FP BID

Treatment:

Drug: Fluticasone Propionate

FLuticasone Propionate (FP) - Arm 4

Experimental group

Description:

FP BID

Treatment:

Drug: Fluticasone Propionate

Fluticasone Propionate (FP) - Arm 5

Experimental group

Description:

FP BID

Treatment:

Drug: Fluticasone Propionate

Placebo - Arm 6

Placebo Comparator group

Description:

Placebo inhalation solution 2mL

Treatment:

Drug: Fluticasone Propionate