| A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
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| 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.
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| To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
|
| Not Provided
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| Interventional
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| Phase 2
|
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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- Pulmonary Disease, Chronic Obstructive
- Lung Diseases
- Lung Diseases, Obstructive
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- 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
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| Not Provided
|
| |
| Completed
|
| 405
|
| 380
|
| December 2010
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| 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 |
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| 40 Years to 80 Years (Adult, Older Adult)
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| No
|
|
Contact information is only displayed when the study is recruiting subjects
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| Argentina, Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Slovakia, South Africa, Spain, Turkey, United States
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| Czech Republic
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| |
| NCT00808288
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| A7881013
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| Yes
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| Not Provided
|
| Not Provided
|
| Pfizer
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| Pfizer
|
| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
|
| February 2019
|
