Eckard Hamelmann, MD, Eric D

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Presentation transcript:

Tiotropium add-on therapy in adolescents with moderate asthma: A 1-year randomized controlled trial Eckard Hamelmann, MD, Eric D. Bateman, MD, Christian Vogelberg, MD, Stanley J. Szefler, MD, Mark Vandewalker, MD, Petra Moroni- Zentgraf, MD, Mandy Avis, PhD, Anna Unseld, MSc, Michael Engel, MD, Attilio L. Boner, MD Journal of Allergy and Clinical Immunology Volume 138, Issue 2, Pages 441-450.e8 (August 2016) DOI: 10.1016/j.jaci.2016.01.011 Copyright © 2016 The Authors Terms and Conditions

Fig 1 CONSORT diagram. Of the patients screened, the main reasons for noninclusion were as follows: adverse event (n = 3), consent withdrawn (n = 11), violation of inclusion or exclusion criteria (n = 243), lost to follow-up (n = 3), and other (n = 15). Of those randomized, 1 patient randomized to 5 μg of tiotropium administered through the Respimat device was not treated. AE, Adverse event; QD, once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig 2 Peak FEV1(0-3h) response at week 24: full analysis set. Results are adjusted for treatment, country, week, baseline, treatment-by-week interaction, and baseline-by-week interaction. Error bars are ± SEs. Common baseline mean FEV1 ± SD is 2747 ± 662 mL. **P < .01 versus placebo Respimat and ***P < .001 versus placebo Respimat. Peak FEV1(0-3h), Peak FEV1 within 3 hours after dosing; QD, once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig 3 Forced expiratory flow between 25% and 75% of FVC (FEF[25-75%]) response at week 24: full analysis set. Results are adjusted for treatment, country, week, baseline, treatment-by-week interaction, and baseline-by-week interaction. Common baseline mean ± SD is 2.48 ± 0.97 L/s. *P < .05 versus placebo Respimat, **P < .01 versus placebo Respimat, and ***P < .001 versus placebo Respimat. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig 4 AQLQ(S)+12 responder rate at week 24 (A) and week 48 (B): full analysis set. Results are adjusted for treatment, country, week, baseline, treatment-by-week interaction, and baseline-by-week interaction. Common baseline mean ± SD is 5.4 ± 0.8. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig 5 Adjusted mean predose morning (A) and evening (B) PEF responses at weeks 24 and 48: full analysis set. Results are adjusted for treatment, country, week, baseline, treatment-by-week interaction, and baseline-by-week interaction. Common baseline mean predose morning PEF ± SD is 339.7 ± 91.5 L/min; common baseline predose evening PEF ± SD is 359.9 ± 91.1 L/min. Adjusted mean predose morning and evening PEF responses versus placebo were as follows: 5 μg of tiotropium, P = .02 and P = .01, respectively, at week 24 and P = .005 and P = .008, respectively, at week 48; 2.5 μg of tiotropium, P = .17 and P = .08, respectively, at week 24 and P = .0504 and P = .03, respectively, at week 48. *P < .05 versus placebo Respimat and **P < .01 versus placebo Respimat. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig E1 Study design. Patients randomized to placebo received background ICS maintenance treatment with or without an LTRA as active therapy only. In-clinic spirometric evaluations were conducted at baseline (visit 2; randomization) and subsequently at visits 4, 6, and 8 in the evening. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig E2 ACQ responder rate analyses: ACQ-6 score at week 24 (A), ACQ-6 score at week 48 (B), ACQ-7 score at week 24 (C), and ACQ-7 score at week 48 (D). The full analysis set is shown. Common baseline mean ACQ-6 score ± SD is 2.0 ± 0.5. ACQ-7 score ± SD is 2.0 ± 0.4. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions

Fig E3 Weekly mean predose morning (A) and evening (B) PEF responses over 48 weeks. The full analysis set is shown. Results are adjusted for treatment, country, week, baseline, treatment-by-week interaction, and baseline-by-week interaction. Common baseline mean predose morning PEF ± SD is 339.7 ± 91.5 L/min; common baseline mean predose evening PEF ± SD is 359.9 ± 91.1 L/min. Adjusted mean predose morning and evening PEF response versus placebo is as follows: 5 μg of tiotropium, P = .02 and P = .01, respectively, at week 24 and P = .005 and P = .008, respectively, at week 48; 2.5 μg of tiotropium, P = .17 and P = .08, respectively, at week 24 and P = .0504 and P = .03, respectively, at week 48. QD, Once daily. Journal of Allergy and Clinical Immunology 2016 138, 441-450.e8DOI: (10.1016/j.jaci.2016.01.011) Copyright © 2016 The Authors Terms and Conditions