12-Week Study in Adult Subjects With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:1/1/2014
Start Date:March 2012
End Date:November 2013
Contact:Ketty Belizaire
Phone:908-542-1999

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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

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.

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.

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.
We found this trial at
1
site
Greenville, South Carolina 29615
?
mi
from
Greenville, SC
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