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Eckard Hamelmann, MD, Eric D

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1 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 e8 (August 2016) DOI: /j.jaci Copyright © 2016 The Authors Terms and Conditions

2 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 Of the patients screened, the main reasons for noninclusion were as follows: adverse event (n = 3), consent withdrawn (n = 11), violation of inclusion or exclusion criteria (n = 243), lost to follow-up (n = 3), and other (n = 15).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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

3 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

4 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

5 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

6 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

7 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

8 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

9 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  , e8DOI: ( /j.jaci ) Copyright © 2016 The Authors Terms and Conditions

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