Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
| NCT number | NCT00062582 |
| Other study ID # | BY217/M2-110 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | June 9, 2003 |
| Last updated | November 22, 2016 |
| Start date | June 2003 |
| 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 aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with COPD.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Main Inclusion Criteria: - Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) - Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main Exclusion Criteria: - Clinical diagnosis of asthma - Poorly controlled COPD - Regular need for daily oxygen therapy |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | ALTANA Pharma | Cities in Argentina | |
| Canada | ALTANA Pharma | Cities in Canada | |
| Colombia | ALTANA Pharma | Cities in Colombia | |
| Mexico | ALTANA Pharma | Cities in Mexico | |
| Peru | ALTANA Pharma | Cities in Peru | |
| United States | ALTANA Pharma | Cities in Alabama | Alabama |
| United States | ALTANA Pharma | Cities in Arizona | Arizona |
| United States | ALTANA Pharma | Cities in California | California |
| United States | ATLANA Pharma | Cities in Colorado | Colorado |
| United States | ALTANA Pharma | Cities in Conneticut | Connecticut |
| United States | ALTANA Pharma | Cities in Delaware | Delaware |
| United States | ALTANA Pharma | Cities in Florida | Florida |
| United States | ALTANA Pharma | Cities in Georgia | Georgia |
| United States | ALTANA Pharma | Cities in Idaho | Idaho |
| United States | ALTANA Pharma | Cities in Indiana | Indiana |
| United States | ALTANA Pharma | Cities in Iowa | Iowa |
| United States | ALTANA Pharma | Cities in Kansas | Kansas |
| United States | ALTANA Pharma | Cities in Kentucky | Kentucky |
| United States | ALTANA Pharma | Cities in Louisiana | Louisiana |
| United States | ALTANA Pharma | Cities in Maryland | Maryland |
| United States | ALTANA Pharma | Cities in Michigan | Michigan |
| United States | ALTANA Pharma | Cities in Missouri | Missouri |
| United States | ALTANA Pharma | Cities in Nebraska | Nebraska |
| United States | ALTANA Pharma | Cities in Nevada | Nevada |
| 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 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 Texas | Texas |
| United States | ALTANA Pharma | Cities in Utah | Utah |
| United States | ALTANA Pharma | Cities in Virginia | Virginia |
| United States | ALTANA Pharma | Cities in Washington | Washington |
| United States | ALTANA Pharma | Cities in West Virginia | West Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Canada, Colombia, Mexico, Peru,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pulmonary function. | |||
| Secondary | exacerbation rate | |||
| Secondary | quality of life | |||
| Secondary | symptoms | |||
| Secondary | use of rescue medication | |||
| Secondary | safety and tolerability. |
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