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Completed

NCT Number: NCT00783406

Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

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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, Berlin, Germany

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 of <0.7.
  • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
  • Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
  • Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion criteria

  • Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
  • History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Treatment and study plan

PF-00610355

Drug

dry powder inhaler, 1472 mcg, single dose

Placebo

Drug

Placebo

Primary outcomes

  1. To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.

    Time frame: up to 8 days post dose

  2. To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients

    Time frame: up to 24 hours post dose

Secondary outcomes

  1. To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.

    Time frame: up to 24 hours post dose

  2. To investigate the exposure/response relationship of PF-00610355.

    Time frame: up to 8 days post dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

Acronym: A7881010

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Nov 1, 2010

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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