A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

Phase 2

Completed

• Conditions: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive
• Interventions: Drug: PF-00610355; Drug: Salmeterol; Drug: PF- 00610355; Drug: Placebo; Drug: PF - 00610355

• Registration Number: NCT00808288
• Lead Sponsor: Pfizer

Brief Summary

To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-12
• Study First Submitted QC: 2008-12-12
• Study First Posted: 2008-12-15
• Study Start: 2010-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2019-02
• Disposition First Submitted: 2019-02-01
• Disposition First Submitted QC: 2019-02-01
• Last Update Submitted: 2019-02-01
• Disposition First Posted: 2019-02-06
• Last Update Posted: 2019-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-00610355	PF-00610355	-
Salmeterol	Salmeterol	-
PF - 00610355	PF- 00610355	-
Placebo	Placebo	-
PF- 00610355	PF - 00610355	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in trough FEV1	6 week

Secondary Outcome Measures

Name	Time	Method
Change from baseline in peak FEV1	0-6 hours /6 weeks
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium	each visit
Change from baseline in trough and peak FEV6, FVC and IC	6 weeks
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)	2 and 4 weeks
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)	2,4,6 weeks
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).	weekly

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇹🇷 Izmir, Turkey