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Completed

NCT Number: NCT00808288

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

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

Completed

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Rosario, Santa Fe Province, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-00610355

Drug

oral, inhaled, dry powder, 600ug, OD

PF - 00610355

Drug

oral, inhaled, dry powder, 300ug, OD

PF- 00610355

Drug

oral, inhaled, dry powder, 100ug, OD

Placebo

Drug

oral, inhaled, dry powder, placebo, OD

Salmeterol

Drug

salmeterol, 50ug, BID

Primary outcomes

  1. Change from baseline in trough FEV1

    Time frame: 6 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Acronym: A7881013

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 15, 2008
Registry last updated
Feb 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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