Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00808288 |
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
Condition | Intervention | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive |
Drug: PF-00610355 Drug: PF - 00610355 Drug: PF- 00610355 Drug: Placebo Drug: Salmeterol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease. |
Estimated Enrollment: | 380 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
PF-00610355: Experimental |
Drug: PF-00610355
oral, inhaled, dry powder, 600ug, OD
|
PF- 00610355: Experimental |
Drug: PF - 00610355
oral, inhaled, dry powder, 300ug, OD
|
PF - 00610355: Experimental |
Drug: PF- 00610355
oral, inhaled, dry powder, 100ug, OD
|
Placebo: Placebo Comparator |
Drug: Placebo
oral, inhaled, dry powder, placebo, OD
|
Salmeterol: Active Comparator |
Drug: Salmeterol
salmeterol, 50ug, BID
|
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A7881013 |
Study First Received: | December 12, 2008 |
Last Updated: | April 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00808288 History of Changes |
Health Authority: | Germany: BfArM |
COPD Respiratory Long acting beta agonist |
Neurotransmitter Agents Salmeterol Adrenergic Agents Adrenergic beta-Agonists Respiration Disorders Anti-Asthmatic Agents Adrenergic Agonists |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |
Respiratory System Agents Disease Attributes Neurotransmitter Agents Salmeterol Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Physiological Effects of Drugs Respiration Disorders Anti-Asthmatic Agents Pharmacologic Actions |
Adrenergic Agonists Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |