Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
| Verified date | September 2016 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
| Status | Completed |
| Enrollment | 1100 |
| Est. completion date | December 2005 |
| Est. primary completion date | December 2005 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Main Inclusion Criteria: - FEV1/FVC ratio (post-bronchodilator) =70% - FEV1 (post-bronchodilator) =50% of predicted - Current smoker or ex-smoker - Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline - Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline Main Exclusion Criteria: - COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline - Lower respiratory tract infection not resolved 4 weeks prior to baseline - Diagnosis of asthma and/or other relevant lung disease - Known alpha-1-antitrypsin deficiency - Need for long-term oxygen therapy defined as =16 hours/day |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | ALTANA Pharma | Cities in Canada | |
| France | ALTANA Pharma | Cities in France | |
| Germany | ALTANA Pharma | Cities in Germany | |
| Poland | ALTANA Pharma | Cities in Poland | |
| South Africa | ALTANA Pharma | Cities in South Africa | |
| United States | ALTANA Pharma | Cities in Alabama | Alabama |
| United States | ALTANA Pharma | Cities in Arizona | Arizona |
| United States | ALTANA Pharma | Cities in Arkansas | Arkansas |
| United States | ALTANA Pharma | Cities in California | California |
| United States | ALTANA Pharma | Cities in Colorado | Colorado |
| United States | ALTANA Pharma | Cities in Connecticut | Connecticut |
| United States | ALTANA Pharma | Cities in Florida | Florida |
| United States | ALTANA Pharma | Cities in Georgia | Georgia |
| United States | ALTANA Pharma | Cities in Illionois | Illinois |
| United States | ALTANA Pharma | Cities in Iowa | Iowa |
| United States | ALTANA Pharma | Cities in Kentucky | Kentucky |
| United States | ALTANA Pharma | Cities in Louisiana | Louisiana |
| United States | ALTANA Pharma | Cities in Massachusetts | Massachusetts |
| United States | ALTANA Pharma | Cities in Minnesota | Minnesota |
| United States | ALTANA Pharma | Cities in Missouri | Missouri |
| United States | ALTANA Pharma | Cities in Montana | Montana |
| United States | ALTANA Pharma | Cities in Nebraska | Nebraska |
| United States | ALTANA Pharma | Cities in Nevada | Nevada |
| United States | ALTANA Pharma | Cities in New Hampshire | New Hampshire |
| United States | ALTANA Pharma | Cities in New Jersey | New Jersey |
| United States | ALTANA Pharma | Cities in New York | New York |
| United States | ALTANA Pharma | Cities in North Carolina | North Carolina |
| United States | ALTANA Pharma | Cities in Ohio | Ohio |
| United States | ALTANA Pharma | Cities in Oklahoma | Oklahoma |
| United States | ALTANA Pharma | Cities in Oregon | Oregon |
| United States | ALTANA Pharma | Cities in Pennsylvania | Pennsylvania |
| United States | ALTANA Pharma | Cities in Rhode Island | Rhode Island |
| United States | ALTANA Pharma | Cities in South Carolina | South Carolina |
| United States | ALTANA Pharma | Cities in Tennessee | Tennessee |
| United States | ALTANA Pharma | Cities in Texas | Texas |
| United States | ALTANA Pharma | Cities in Utah | Utah |
| United States | ALTANA Pharma | Cities in Vermont | Vermont |
| United States | ALTANA Pharma | Cities in Virginia | Virginia |
| United States | ALTANA Pharma | Cities in West Virginia | West Virginia |
| United States | ALTANA Pharma | Cities in Wisconsin | Wisconsin |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Canada, France, Germany, Poland, South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in FEV1 from baseline during the treatment period; number of COPD exacerbations. | |||
| Secondary | pulmonary function variables | |||
| Secondary | number of COPD exacerbations of different type and various subgroups | |||
| Secondary | quality of life variables | |||
| Secondary | patient diary variables | |||
| Secondary | time to study withdrawal | |||
| Secondary | safety. |
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