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Completed

NCT Number: NCT00468975

A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Reversible asthmatic patients (>15% increase in FEV1 following 200ug salbutamol).
  • FEV1 greater than or equal to 60% predicted
  • Stable disease for at least the previous 3 months

Exclusion criteria

  • Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening
  • Subjects with a history of pulmonary disease other than asthma.

Treatment and study plan

PF-610,355

Drug

Salmeterol

Drug

Primary outcomes

  1. Peak and Trough (24 hour post dose) FEV1.

Secondary outcomes

  1. Peak and trough (24 hour post dose) PEFR

  2. FEV1 and PEFR measurements to 32 hours post dose.

  3. Pharmacokinetics of PF-610,355 and salmeterol

  4. Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients

Important dates

Study start
2007
First posted
May 3, 2007
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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