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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.

ABSTRACT: Asthma guidelines suggest that therapy can be reduced once asthma is controlled. Despite these recommendations, asthmatic patients are seldom stepped down in clinical practice, and questions remain about when and how to reduce asthma therapy. The purpose of the present study was to evaluate lung function and asthma control in patients who were stepped down from the highest recommended dose of inhaled corticosteroid/long acting ?2 agonist combination therapy.This was a prospective, randomised, controlled, two-arm parallel group study. Asthmatic patients who were fully controlled with a high daily dose (1000/100??g) of fluticasone/salmeterol were randomly assigned to 6?months of open-label treatment with either 500/100??g fluticasone/salmeterol Diskus daily or 400/24??g extrafine beclomethasone/formoterol pMDI daily. The primary outcome was the change in morning peak expiratory flow (PEF) values between baseline and the end of treatment. The secondary outcomes included asthma control and exacerbation frequency.Four hundred twenty-two patients were included in the analysis. The PEF values remained above 95% of the predicted values throughout the study. The end-study morning PEF rates showed equivalence between the groups (difference between means, 2.49?L/min; 95% CI, -13.43 to 18.42). No changes from baseline were detected in PEF and forced expiratory volume in 1 second measured at the clinics, in the symptom scores or in the use of rescue medication. Asthma control was maintained in 95.2% of the patients at 6?months. No significant differences between the groups were detected in any other parameter, including exacerbation frequency and adverse events.Stepping down patients whose asthma is controlled with the highest recommended dose of fluticasone/salmeterol to either 500/100??g fluticasone/salmeterol daily or 400/24??g extra-fine beclomethasone/formoterol daily provides comparable maintenance of lung function and asthma control.clinicaltrials.gov NCT00497237.

SUBMITTER: Papi A

PROVIDER: S-EPMC3431221 | biostudies-literature | 2012 Jun

REPOSITORIES: biostudies-literature

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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.

Papi Alberto A Nicolini Gabriele G Crimi Nunzio N Fabbri Leonardo L Olivieri Dario D Rossi Andrea A Paggiaro Pierluigi P

Respiratory research 20120625

<h4>Background</h4>Asthma guidelines suggest that therapy can be reduced once asthma is controlled. Despite these recommendations, asthmatic patients are seldom stepped down in clinical practice, and questions remain about when and how to reduce asthma therapy. The purpose of the present study was to evaluate lung function and asthma control in patients who were stepped down from the highest recommended dose of inhaled corticosteroid/long acting β2 agonist combination therapy.<h4>Methods</h4>Thi ...[more]

PMID: 22731754

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Project description:IntroductionDuring the clinical development of a fixed-dose combination of drugs, it is best practice to conduct dose-finding studies to determine the optimal dose of each component. The aims of this phase II dose-finding study were to confirm the lung function benefit of adding olodaterol to tiotropium, describe the dose-response relationship of olodaterol in combination with tiotropium 5 μg, and compare it with the dose response of olodaterol monotherapy.MethodsIn this double-blind, parallel-group trial, patients were randomized to receive either tiotropium 5 μg or a fixed-dose combination of tiotropium 5 μg with olodaterol 2 μg, 5 μg, or 10 μg, delivered once daily via the Respimat® for 4 weeks (NCT00696020). Patients had a diagnosis of chronic obstructive pulmonary disease and post-bronchodilator forced expiratory volume in 1 s (FEV1) ≥ 30 and < 80% of predicted normal. The primary endpoint was trough FEV1 response (change from baseline) after 4 weeks. Secondary endpoints included FEV1 and forced vital capacity (FVC) over 6 h after dosing.ResultsCompared with tiotropium 5 μg, mean (standard error) trough FEV1 increased with the addition of olodaterol 2 μg by 0.024 L (0.027), olodaterol 5 μg by 0.033 L (0.027), and olodaterol 10 μg by 0.057 L (0.027). Statistically significant improvements in FEV1 versus tiotropium were seen across all timepoints up to 6 h with all doses of tiotropium/olodaterol. Similar results were observed for FVC.ConclusionThere was a benefit of tiotropium/olodaterol compared with tiotropium monotherapy in FEV1 and FVC. There was a dose-response relationship for olodaterol on top of tiotropium for FEV1 and FVC similar to the dose response previously seen for olodaterol monotherapy. These results, together with the results of a study investigating the dose response of tiotropium on top of olodaterol, helped to inform the dose selection for the phase III studies.FundingBoehringer Ingelheim International GmbH.

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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.

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Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial.

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