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Original Research: COPD |

Response to Add-on Inhaled Corticosteroids in COPD Based on Airway Hyperresponsiveness to MannitolInhaled Corticosteroids in COPD

Andreas Scherr, MD; Salome Schafroth Török, MD; Anja Jochmann, MD; David Miedinger, MD; Sabrina Maier, RN; Anne B. Taegtmeyer, MBBS,, PhD; Prashant N. Chhajed, MBBS, MD, FCCP; Michael Tamm, MD, FCCP; Joerg D. Leuppi, MD, PhD
Author and Funding Information

From the Clinic of Respiratory Medicine (Drs Scherr and Tamm), Clinic of Internal Medicine (Drs Scherr, Schafroth Török, Jochmann, Miedinger, Chhajed, and Leuppi and Ms Maier), and Clinic of Clinical Pharmacology and Toxicology (Dr Taegtmeyer), University Hospital Basel, Basel, Switzerland.

Correspondence to: Joerg D. Leuppi, MD, PhD, Clinic of Internal Medicine, University Hospital Basel, University of Basel, Petersgraben 4, CH-4031 Basel, Switzerland; e-mail: jleuppi@uhbs.ch


Drs Scherr and Schafroth Török contributed equally.

Funding/Support: The study was supported financially by a grant from Boehringer Ingelheim GmbH, Switzerland, who also provided tiotropium for study use, and Pharmaxis Ltd, Australia provided the mannitol tests.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2012;142(4):919-926. doi:10.1378/chest.11-2535
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Background:  The use of inhaled corticosteroids in mild to moderate COPD is controversial. The aim of this study was to determine whether airway hyperresponsiveness to mannitol might identify patients who are likely to respond to add-on inhaled corticosteroids.

Methods:  Ninety subjects with mild to moderate COPD were recruited and 68 subsequently randomized in a double-blind manner to receive inhaled budesonide (1,600 μg/d, n = 31) or placebo (n = 37) for 3 months. Thirty-eight subjects had airway hyperresponsiveness to mannitol (17 received budesonide, 21 placebo). All subjects received tiotropium throughout the study, including 4 weeks before randomization. Spirometry, quality of life (St. George Respiratory Questionnaire), degree of dyspnea, airway responsiveness to mannitol, and exhaled nitric oxide were assessed at week 0 (recruitment), week 4 (baseline prior to randomization), and week 16 (posttreatment).

Results:  Compared with placebo, budesonide was associated with improved quality of life in subjects showing airway hyperresponsiveness to mannitol (difference of changes in quality of life score between randomization and study completion, −9.1; 95% CI, −15.8 to −2.3; P < .01). Treatment with inhaled budesonide also led to a reduction in airway responsiveness to mannitol compared with placebo (difference in log10 response-dose ratio, −0.3; 95% CI, −0.6 to −0.04; P < .01). However, postrandomization changes in FEV1 % predicted, quality of life, and exhaled nitric oxide showed no difference between budesonide and placebo.

Conclusions:  In subjects with mild to moderate COPD and airway hyperresponsiveness to mannitol, quality of life and airway responsiveness improved after treatment with inhaled corticosteroids added to long-acting bronchodilator therapy.

Trial registry:  ClinicalTrials.gov; No.: NCT00860938; URL: www.clinicaltrials.gov

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