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The purpose of this study is to confirm the dose of roflumilast to be used for asthma management by comparing the effects of 250 mcg and 500 mcg oral roflumilast with placebo on pulmonary function and asthma symptoms.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Roflumilast | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| change in lung function. |
| Measure | Description | Time Frame |
|---|---|---|
| change in morning PEF | ||
| asthma symptom score | ||
| rescue medication |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca AstraZeneca | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ALTANA Pharma | Cities in Alabama | Alabama | United States | |||
| ALTANA Pharma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26612545 | Derived | Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22. | |
| 26498386 | Derived | Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21. |
| Label | URL |
|---|---|
| BY217-M2-023-RDS-2007-01-23.pdf | View source |
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| time to withdrawal due to worsening asthma. |
| 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 Delaware | Delaware | United States |
| ALTANA Pharma | Cities in Florida | Florida | United States |
| ALTANA Pharma | Cities in Georgia | Georgia | United States |
| ALTANA Pharma | Cities in Illinois | Illinois | United States |
| ALTANA Pharma | Cities in Indiana | Indiana | 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 Maine | Maine | United States |
| ALTANA Pharma | Cities in Maryland | Maryland | United States |
| ALTANA Pharma | Cities in Massachusetts | Massachusetts | United States |
| ALTANA Pharma | Cities in Michigan | Michigan | 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 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 Washington | Washington | United States |
| ALTANA Pharma | Cities in West Virginia | West Virginia | United States |
| ALTANA Pharma | Cities in Russia | Russia |
| ALTANA Pharma | Cities in the Ukraine | Ukraine |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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