Correlation of airway obstruction and patient-reported endpoints in clinical studies

Eur Respir J. 2001 Feb;17(2):220-4. doi: 10.1183/09031936.01.17202200.

Abstract

To establish the correlation among asthma efficacy parameters over a long period, data from over 1,500 patients in two one-year asthma clinical trials with montelukast, a Cys-LT1 antagonist, were analysed. Airway obstruction measurements, forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF), were measured at clinic visits. Patients recorded daytime symptom score, "as-needed" beta-agonist use, and PEF on a daily basis. Relationships among these parameters at baseline and during the one-year treatment period were established by correlation analyses. Multiple correlations between the airway obstruction (FEV1 and PEF) and patient-reported measurements were evaluated by canonical correlation analysis. Pairwise correlations of the efficacy parameters over a one-year time period were stable. Canonical correlation between the airway obstruction and patient-reported asthma efficacy endpoints was low, indicating that each category of endpoints measures a distinctively different aspect of the disease. It appears that at least one endpoint from each category should be used in asthma clinical studies.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / therapeutic use
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Asthmatic Agents / therapeutic use*
  • Asthma / drug therapy
  • Asthma / physiopathology*
  • Clinical Trials as Topic
  • Cyclopropanes
  • Cysteine / antagonists & inhibitors
  • Endpoint Determination
  • Female
  • Follow-Up Studies
  • Forced Expiratory Volume
  • Humans
  • Leukotriene Antagonists / therapeutic use
  • Leukotrienes*
  • Male
  • Middle Aged
  • Peak Expiratory Flow Rate
  • Pulmonary Ventilation / drug effects*
  • Quinolines / therapeutic use
  • Sulfides
  • Treatment Outcome

Substances

  • Acetates
  • Anti-Asthmatic Agents
  • Cyclopropanes
  • Leukotriene Antagonists
  • Leukotrienes
  • Quinolines
  • Sulfides
  • cysteinyl-leukotriene
  • Cysteine
  • montelukast