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Completed

NCT Number: NCT00292838

Relative Potency of Inhaled Corticosteroids

To investigate the validity of a clinical model to determine the relative potency of different preparations of inhaled corticosteroids used for the treatment of asthma or of eosinophilic bronchitis without asthma.

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Key information

Conditions

Asthma Bronchial Diseases Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Firestone Institute for Respiratory Health, St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Sputum eosinophilia >3%
  • Adults age 18-70 years
  • History of episodic wheeze, chest tightness, dyspnea or cough within the last 12 months.
  • FEV1 ≥ 60% predicted
  • Steroid naive or on not more than 500 µg a day of beclomethasone or equivalent.
  • Able to give written informed consent

Exclusion criteria

  • Recent asthma or COPD exacerbation (as judged by the clinician) due to respiratory infection within the last month
  • Relevant seasonal allergen exposure within 4 weeks or within the course of the study
  • Treatment with prednisone or antibiotics or hospitalisation within the past 6 weeks
  • Other respiratory diseases
  • Women who are pregnant or unwilling to use appropriate contraception during the study
  • Unable to withhold short-acting ß-agonist treatment for 6 hours before visit

Treatment and study plan

fluticasone 25, 50, 100, 200 mcg

Drug

Primary outcomes

  1. Sputum eosinophils

Secondary outcomes

  1. Exhaled nitric oxide, FEV1, FEF25-75%

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

Relative Potency of Inhaled Corticosteroids: Validation of a Clinical Model

Important dates

Study start
2001
Primary completion
2007
Study completion
2007
First posted
Feb 16, 2006
Registry last updated
Jul 20, 2011

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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