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| A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. |
| 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. |
| To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD) |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
- Pulmonary Disease, Chronic Obstructive
- Lung Diseases
- Lung Diseases, Obstructive
|
- Drug: PF-00610355
oral, inhaled, dry powder, 600ug, OD - Drug: PF - 00610355
oral, inhaled, dry powder, 300ug, OD - Drug: PF- 00610355
oral, inhaled, dry powder, 100ug, OD - Drug: Placebo
oral, inhaled, dry powder, placebo, OD - Drug: Salmeterol
salmeterol, 50ug, BID
|
- Experimental: PF-00610355
Intervention: Drug: PF-00610355 - Experimental: PF- 00610355
Intervention: Drug: PF - 00610355 - Experimental: PF - 00610355
Intervention: Drug: PF- 00610355 - Placebo Comparator: Placebo
Intervention: Drug: Placebo - Active Comparator: Salmeterol
Intervention: Drug: Salmeterol
|
| Not Provided |
|
| |
|
| Completed |
| 405 |
| 380 |
| December 2010 |
| December 2010 (Final data collection date for primary outcome measure) |
Inclusion Criteria: - Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
- Diagnosis of moderate COPD for a minimum of 6 months.
- Stable disease for at least 1 month prior to screening
Exclusion Criteria: - More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
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| Sexes Eligible for Study: | All |
|
| 40 Years to 80 Years (Adult, Older Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Argentina, Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Slovakia, South Africa, Spain, Turkey, United States |
| Czech Republic |
| |
|
| NCT00808288 |
| A7881013 |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
|
| Pfizer |
| February 2019 |
|
