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Table of Contents
Vol. 73, No. 4, 2006
Issue release date: June 2006
Section title: Clinical Investigations
Respiration 2006;73:449–456
(DOI:10.1159/000090898)

Double-Blind, Randomised, Controlled Trial Assessing Controller Medications in Asthma

Shah A.R. · Sharples L.D. · Solanki R.N. · Shah K.V.
Department of Chest Diseases, Civil Hospital, Ahmedabad, India

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Article / Publication Details

First-Page Preview
Abstract of Clinical Investigations

Published online: July 05, 2006
Issue release date: June 2006

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 3

ISSN: 0025-7931 (Print)
eISSN: 1423-0356 (Online)

For additional information: http://www.karger.com/RES

Abstract

Background: The motive behind conducting this study was to determine if better control of asthma can be achieved by adding a second controller medication and to assess its use to reduce the dose of inhaled steroids. Objectives: The study aimed to determine whether either oral sustained-release theophylline or montelukast added to inhaled steroids improved clinical symptoms and pulmonary function test parameters when compared to high-dose steroids alone. Methods: Ninety patients with incompletely controlled asthma were allocated, in a randomised, double-blind fashion, to one of three treatment groups: group A: double dose of inhaled budesonide (400 µg b.i.d.), group B: 400 mg oral sustained-release theophylline plus budesonide (200 µg b.i.d.) and group C: 10 mg montelukast plus budesonide (200 µg b.i.d.). The primary endpoints were forced expiratory volume in 1 s (FEV1) and mean morning peak expiratory flow rate (PEFR). Results: All three groups had improved FEV1 and PEFR at 8 weeks (p < 0.001). Group C increased their PEFR by 18.7 l/min (95% confidence interval, CI, 12.4–25.1) more than group A and by 19.8 l/min (95% CI 13.4–26.1) more than group B (both p = 0.001). Similarly, group C had a 114 ml (95% CI 45–183 ml) greater improvement in FEV1 than group A and a 95 ml (95% CI 26–164 ml) greater improvement than group B (both p = 0.01). Conclusions: Addition of montelukast to budesonide is safe and results in greater improvement in pulmonary function test parameters than high-dose budesonide treatment or addition of theophylline.

© 2006 S. Karger AG, Basel


Article / Publication Details

First-Page Preview
Abstract of Clinical Investigations

Published online: July 05, 2006
Issue release date: June 2006

Number of Print Pages: 8
Number of Figures: 3
Number of Tables: 3

ISSN: 0025-7931 (Print)
eISSN: 1423-0356 (Online)

For additional information: http://www.karger.com/RES


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