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The study is aimed at evaluating efficacy and safety of oglemilast in the treatment of stable mild to moderate persistent asthma. The study involves two weeks of run in period. This is a placebo controlled study. One of the four treatment arms is placebo. The duration of treatment is 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. oglemilast | Experimental |
| |
| 2. oglemilast | Experimental |
| |
| 3. oglemilast | Experimental |
| |
| 4. placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oglemilast | Drug | Tablet oglemilast or placebo once a day, for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morning pre-dose FEV1 at day 85 compared with pre-dose FEV1 value at day 1 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline at days 8, 36 and 64 in morning pre-dose FEV1 | Days 8, 36, 64 | |
| Change from baseline at days 8, 36 and 64 in morning pre-dose vital capacity (FVC), peak expiratory flow (PEF), forced expiratory flow 25-75% (FEF25-75%) | days 8, 36 and 64 |
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Eligibility Criteria:
The following criteria must be met at the randomisation visit:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenmark investigational sites (28) | Mumbai, Bangalore Etc | India |
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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 |
|---|---|
| C506613 | oglemilast |
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| Change from baseline in morning and evening PEF (based on patient diary) | 12 weeks |
| Change in asthma day time symptom score from baseline at day 85 | 12 weeks |
| Change in asthma night time symptom score from baseline at day 85 | 12 weeks |
| Change in number of night time awakenings from baseline at day 85 | 12 weeks |
| Frequency and the use of rescue (reliever) medication (salbutamol) | 12 weeks |
| Frequency and severity of asthma exacerbations | 12 weeks |
| Investigator global impression of change from baseline to day 85 | 12 weeks |
| Patient global impression of change from baseline to day 85 | 12 weeks |
| Pharmacokinetic parameters of oglemilast | 12 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |