Dataset Information

Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.

ABSTRACT:

Rationale

Long-acting beta-agonists (LABAs) and inhaled corticosteroids administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABAs (improved lung function) and leukotriene receptor antagonists (LTRAs; protection against exacerbations) may be complementary as well.

Objective

We sought to determine whether the combination of the LTRA montelukast and the LABA salmeterol could provide an effective therapeutic strategy for asthma.

Methods and measurements

In a randomized, placebo-controlled, crossover study of 192 subjects with moderate asthma, we compared the clinical efficacy of regular treatment over 14 weeks with the combination of montelukast and salmeterol to that with the combination of beclomethasone and salmeterol in moderate asthma. The primary efficacy outcome was time to treatment failure.

Main results

Three months after the randomization of the last subject, the Data and Safety Monitoring Board determined that the primary research question had been answered and terminated the trial. The combination of montelukast and salmeterol was inferior to the combination of beclomethasone and salmeterol as judged by protection against asthma treatment failures (p = 0.0008), lung function (26 L/min difference in a.m. peak expiratory flow rate, p = 0.011), asthma control score (0.22 difference in Asthma Control Questionnaire score, p = 0.038), and markers of inflammation and airway reactivity.

Conclusions

Patients with moderate asthma similar to those we studied should not substitute the combination of an LTRA and an LABA for the combination of inhaled corticosteroid and an LABA.

SUBMITTER: Deykin A

PROVIDER: S-EPMC1899264 | biostudies-literature | 2007 Feb

REPOSITORIES: biostudies-literature

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Publications

Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.

Deykin Aaron A Wechsler Michael E ME Boushey Homer A HA Chinchilli Vernon M VM Kunselman Susan J SJ Craig Timothy J TJ DiMango Emily E Fahy John V JV Kraft Monica M Leone Frank F Lazarus Stephen C SC Lemanske Robert F RF Martin Richard J RJ Pesola Gene R GR Peters Stephen P SP Sorkness Christine A CA Szefler Stanley J SJ Israel Elliot E

American journal of respiratory and critical care medicine 20060914 3

<h4>Rationale</h4>Long-acting beta-agonists (LABAs) and inhaled corticosteroids administered together appear to be complementary in terms of effects on asthma control. The elements of asthma control achieved by LABAs (improved lung function) and leukotriene receptor antagonists (LTRAs; protection against exacerbations) may be complementary as well.<h4>Objective</h4>We sought to determine whether the combination of the LTRA montelukast and the LABA salmeterol could provide an effective therapeuti ...[more]

PMID: 16973987

Similar Datasets

Project description:INTRODUCTION:Comparative data on the efficacies of long-acting muscarinic antagonist (LAMA) and long-acting ?2-agonist (LABA) combinations for the treatment of moderate-to-very-severe chronic obstructive pulmonary disease (COPD) are limited. The aim of this Bayesian network meta-analysis (NMA) is to assess the relative efficacies of available open combinations (delivered via separate inhalers) and fixed-dose combinations (FDCs, delivered via a single inhaler). METHODS:We conducted a systematic literature review with the aim of identifying randomized controlled trials (RCTs) of ?8-week duration in adults aged ?40 years with COPD that compared LAMA + LABA combinations with each other, with tiotropium (TIO), or with placebo. Data on changes from baseline in trough forced expiratory volume in 1 s (FEV1) and on St George's Respiratory Questionnaire (SGRQ) total score, the Transition Dyspnea Index (TDI) focal score, and rescue medication use at 12 and 24 weeks were extracted from these RCTs and analyzed using a NMA in a Bayesian framework. RESULTS:Data from 44 RCTs were included in the NMA. All FDCs showed improvements relative to placebo in terms of trough FEV1, SGRQ total score, and TDI focal score above clinically relevant thresholds, with the exception of TIO/olodaterol and aclidinium/formoterol, both of which failed to show clinically relevant improvements in SGRQ score at 24 weeks. All FDCs demonstrated reduced rescue medication use versus placebo. Open combinations demonstrated improved efficacy in all outcomes versus placebo, but these improvements did not consistently exceed clinically relevant thresholds for SGRQ and TDI scores. All once-daily FDCs showed improved efficacy versus TIO, but improvements were less consistently observed versus TIO with open dual combinations and combinations containing formoterol or salmeterol administered twice daily. Relative probabilities of improvement between FDCs highlighted potential between-class differences for trough FEV1 but suggested little potential for differences in patient-reported outcomes. CONCLUSION:LAMA + LABA combinations generally showed improved outcomes versus placebo and TIO. FDCs appeared to perform better than open dual combinations. A potential effectiveness gradient was observed between FDCs for objectively assessed functional outcomes, although further prospective trials are required to confirm these findings. FUNDING:GSK.

Dataset Information

Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.

Rationale

Objective

Methods and measurements

Main results

Conclusions

Publications

Combination therapy with a long-acting beta-agonist and a leukotriene antagonist in moderate asthma.

Similar Datasets

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