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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.
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.
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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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Propionate (FP) | Drug | FP Inhalation BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 (Forced Expiry Volume in 1 second) | FEV1 at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Expiratory Flow Rate (PEFR) | PEFR at Week 12 |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Imtiaz Chaudry | Dey | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CU Pharmaceutical Research | Rock Hill | South Carolina | 29732 | 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 |