Asthma Clinical Trial
Official title:
A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
| 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 effects of oral roflumilast with placebo on lung function in patients with asthma.
| Status | Completed |
| Enrollment | 819 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Main Inclusion Criteria: - Persistent bronchial asthma - No change in asthma treatment within 4 weeks prior to visit 1 - Non-smoker or ex-smoker (for 12 months or longer) Main Exclusion Criteria: - Poorly controlled asthma or seasonal asthma - History of lower airway infection four weeks prior to visit 1 - Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease - Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1 - Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection - Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1 - Patients with chronic heart failure - Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol - Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females - Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | ALTANA Pharma | Cities in Argentina | |
| 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 Arkansas | Arkansas |
| United States | ALTANA Pharma | Cities in California | California |
| United States | ALTANA Pharma | Cities in Colorado | Colorado |
| 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 Illinois | Illinois |
| 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 Minnesota | Minnesota |
| United States | ALTANA Pharma | Cities in Mississippi | Mississippi |
| 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 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 North Dakota | North Dakota |
| 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 Virginia | Virginia |
| United States | ALTANA Pharma | Cities in Washington | Washington |
| United States | ALTANA Pharma | Cities in Wisconsin | Wisconsin |
| United States | ALTANA Pharma | Massachusetts | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Argentina, Colombia, Mexico, Peru,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in lung function from baseline to final visit. | |||
| Secondary | pulmonary function variables | |||
| Secondary | diary variables | |||
| Secondary | quality of life variables | |||
| Secondary | time to first exacerbation | |||
| Secondary | number of asthma exacerbations | |||
| Secondary | safety. |
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