HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Permissions Request Permissions Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Web of Science (41) Citing Articles via Google Scholar Google Scholar Articles by Shingo, S. Articles by Reiss, T.F. Search for Related Content PubMed PubMed Citation Articles by Shingo, S. Articles by Reiss, T.F.

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.

This article has been cited by other articles:

				H. K. Reddel, D. R. Taylor, E. D. Bateman, L.-P. Boulet, H. A. Boushey, W. W. Busse, T. B. Casale, P. Chanez, P. L. Enright, P. G. Gibson, et al. An Official American Thoracic Society/European Respiratory Society Statement: Asthma Control and Exacerbations: Standardizing Endpoints for Clinical Asthma Trials and Clinical Practice Am. J. Respir. Crit. Care Med., July 1, 2009; 180(1): 59 - 99. [Abstract] [Full Text] [PDF]

				D. M. LANG New asthma guidelines emphasize control, regular monitoring Cleveland Clinic Journal of Medicine, September 1, 2008; 75(9): 641 - 653. [Abstract] [Full Text] [PDF]

				E. A. Hahn, D. Cella, O. Chassany, D. L. Fairclough, G. Y. Wong, R. D. Hays, and Clinical Significance Consensus Meeting Group Precision of Health-Related Quality-of-Life Data Compared With Other Clinical Measures Mayo Clin. Proc., October 1, 2007; 82(10): 1244 - 1254. [Abstract] [Full Text] [PDF]

				L. B. Bacharier, R. C. Strunk, D. Mauger, D. White, R. F. Lemanske Jr., and C. A. Sorkness Classifying Asthma Severity in Children: Mismatch Between Symptoms, Medication Use, and Lung Function Am. J. Respir. Crit. Care Med., August 15, 2004; 170(4): 426 - 432. [Abstract] [Full Text] [PDF]

				G. L. Colice Categorizing Asthma Severity: An Overview of National Guidelines Clin. Med. Res., August 1, 2004; 2(3): 155 - 163. [Abstract] [Full Text] [PDF]