A Clinical Study of Oglemilast in Patients With Mild to Moderate Persistent Asthma
NCT ID: NCT00859404
Last Updated: 2009-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
282 participants
INTERVENTIONAL
2008-10-31
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1. oglemilast
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
2. oglemilast
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
3. oglemilast
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
4. placebo
oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
Interventions
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oglemilast
Tablet oglemilast or placebo once a day, for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Adult patients with a physician-documented diagnosis of chronic, stable, persistent, mild to moderate asthma (clinical symptoms and documented reversibility of airway obstruction, with an FEV1 of 60% to 85% of the predicted value).
The following criteria must be met at the randomisation visit:
* At least 80% compliance during the single-blind placebo run-in period
* FEV1 between 60% and 85% of the predicted value
* Without asthma exacerbation during the run-in period
* Reversibility: patients are required to demonstrate a ≥ 12% increase in FEV1 (with an absolute improvement in FEV1 of at least 200mL) ≥ 10 min and up to 15 minutes after inhalation of 400 μg salbutamol via a spacer
* Any symptom score being ≥ 1 for at least 4 out of the last 7 days of the run-in
* Use of salbutamol for symptom relief on \> 2 occasions on at least 4 out of the last 7 days of the run-in
18 Years
65 Years
ALL
No
Sponsors
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Glenmark Pharmaceuticals Europe Ltd. (R&D)
INDUSTRY
Responsible Party
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Glenmark Pharmaceuticals Ltd
Locations
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Glenmark investigational sites (28)
Mumbai, Bangalore Etc, , India
Countries
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Other Identifiers
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GRC 3886-201
Identifier Type: -
Identifier Source: org_study_id
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