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

¹ Dept of Clinical Biostatistics, Merck Research Laboratories, Rahway, NJ 07065, USA and ² Dept of Pulmonary and Immunology, Merck Research Laboratories, Rahway, NJ 07065, USA

CORRESPONDENCE: S. Shingo, Merck Research Laboratories, PO Box 2000, RY33–404, Rahway, NJ 07065, USA. Fax: 1 7325946075

Keywords: "as-needed" ß-agonist use, asthma, correlation, FEV₁, PEF, symptom

Received: August 12, 1999
Accepted March 23, 2000

This work was supported by a grant from Merck Research Laboratories, Rahway, NJ, USA.

To establish the correlation among asthma efficacy parameters over a long period, data from over 1500 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" ß-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.

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