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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Propionate (FP) - arm 1 | Experimental | FP BID (twice daily) |
|
| Fluticasone propionate (FP) - arm 2 | Experimental | FP BID |
|
| Fluticasone Propionate (FP) - arm 3 | Experimental | FP BID |
|
| FLuticasone Propionate (FP) - Arm 4 | Experimental | FP BID |
|
| Fluticasone Propionate (FP) - Arm 5 | Experimental | FP BID |
|
| Placebo - Arm 6 | Placebo Comparator | Placebo inhalation solution 2mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate | Drug | FP BID for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 (Forced Expiry Volume in 1 second) | Change in FEV1 at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Expiratory Flow Rate (PEFR) | PEFR at Week 12 |
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Inclusion Criteria:
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:
Agreement by subject to abide by the study protocol and its restrictions.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Imtiaz Chaudry | Dey Pharma, L.P. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenville Pharmaceutical research, Inc. | Greenville | South Carolina | 29615 | United States |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |