Document Detail

Clinical trial of low-dose theophylline and montelukast in patients with poorly controlled asthma.
MedLine Citation:
PMID:  16998094     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Asthma treatment guidelines recommend addition of controller medications for patients with poorly controlled asthma. We compared the effectiveness of once-daily oral controller therapy with either an antileukotriene receptor antagonist (montelukast) or low-dose theophylline added to existing medications in patients with poorly controlled asthma.
METHODS: We conducted a randomized, double-masked, placebo-controlled trial in 489 participants with poorly controlled asthma randomly assigned to placebo, theophylline (300 mg/d), or montelukast (10 mg/d). Participants were monitored for 24 wk to measure the rate of episodes of poor asthma control (EPACs) defined by decreased peak flow, increased beta-agonist use, increased oral corticosteroid use, or unscheduled health care visits.
OBSERVATIONS: There was no significant difference in EPAC rates (events/person/yr) compared with placebo: low-dose theophylline, 4.9 (95% confidence interval [CI], 3.6-6.7; not significant); montelukast, 4.0 (95% CI, 3.0-5.4; not significant); and placebo, 4.9 (95% CI, 3.8-6.4). Both montelukast and theophylline caused small improvements in prebronchodilator FEV(1) of borderline significance. Nausea was more common with theophylline only during the first 4 wk of treatment. Neither treatment improved asthma symptoms or quality of life. However, in patients not receiving inhaled corticosteroids, addition of low-dose theophylline significantly (p < 0.002) improved asthma control and symptoms as well as lung function.
CONCLUSIONS: Neither montelukast nor low-dose theophylline lowered the EPAC rate of poor asthma control in patients with poorly controlled asthma despite improved lung function. For patients not using inhaled corticosteroids, low-dose theophylline improved asthma symptom control more than montelukast or placebo, and provides a safe and low-cost alternative asthma treatment.
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2006-09-22
Journal Detail:
Title:  American journal of respiratory and critical care medicine     Volume:  175     ISSN:  1073-449X     ISO Abbreviation:  Am. J. Respir. Crit. Care Med.     Publication Date:  2007 Feb 
Date Detail:
Created Date:  2007-01-19     Completed Date:  2007-03-09     Revised Date:  2014-09-24    
Medline Journal Info:
Nlm Unique ID:  9421642     Medline TA:  Am J Respir Crit Care Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  235-42     Citation Subset:  AIM; IM    
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MeSH Terms
Acetates / administration & dosage,  therapeutic use*
Administration, Inhalation
Anti-Asthmatic Agents / administration & dosage,  therapeutic use*
Asthma / diagnosis*,  drug therapy*
Double-Blind Method
Drug Therapy, Combination
Forced Expiratory Flow Rates
Glucocorticoids / administration & dosage
Leukotriene Antagonists / administration & dosage,  therapeutic use*
Lung / drug effects,  physiopathology
Middle Aged
Quinolines / administration & dosage,  therapeutic use*
Severity of Illness Index
Theophylline / administration & dosage,  therapeutic use*
Treatment Outcome
Grant Support
Reg. No./Substance:
0/Acetates; 0/Anti-Asthmatic Agents; 0/Glucocorticoids; 0/Leukotriene Antagonists; 0/Quinolines; C137DTR5RG/Theophylline; MHM278SD3E/montelukast
Comment In:
ACP J Club. 2007 Jul-Aug;147(1):8   [PMID:  17608373 ]
Evid Based Med. 2007 Aug;12(4):115   [PMID:  17885163 ]
Am J Respir Crit Care Med. 2007 Sep 1;176(5):520-1; author reply 521-2   [PMID:  17715383 ]
Am J Respir Crit Care Med. 2007 Feb 1;175(3):208-9   [PMID:  17234908 ]
Am J Respir Crit Care Med. 2007 May 15;175(10):1094; author reply 1094-5   [PMID:  17478625 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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