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A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. (A7881013)

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ClinicalTrials.gov Identifier: NCT00808288
Recruitment Status : Completed
First Posted : December 15, 2008
Last Update Posted : October 10, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Lung Diseases Lung Diseases, Obstructive Drug: PF-00610355 Drug: PF - 00610355 Drug: PF- 00610355 Drug: Placebo Drug: Salmeterol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Study Start Date : March 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PF-00610355 Drug: PF-00610355
oral, inhaled, dry powder, 600ug, OD
Experimental: PF- 00610355 Drug: PF - 00610355
oral, inhaled, dry powder, 300ug, OD
Experimental: PF - 00610355 Drug: PF- 00610355
oral, inhaled, dry powder, 100ug, OD
Placebo Comparator: Placebo Drug: Placebo
oral, inhaled, dry powder, placebo, OD
Active Comparator: Salmeterol Drug: Salmeterol
salmeterol, 50ug, BID



Primary Outcome Measures :
  1. Change from baseline in trough FEV1 [ Time Frame: 6 week ]

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


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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00808288


  Show 75 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00808288     History of Changes
Other Study ID Numbers: A7881013
First Posted: December 15, 2008    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011

Keywords provided by Pfizer:
COPD Respiratory Long acting beta agonist

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action