0
Pediatrics |

Once-Daily Tiotropium Respimat Add-On to Medium-Dose ICS Is an Efficacious 24-Hour Bronchodilator in Adolescent Patients With Symptomatic Asthma

Christian Vogelberg; Michael Engel; Petra Moroni-Zentgraf; Migle Leonaviciute-Klimantaviciene; Ralf Sigmund; John Downie; Viktorija Vevere; Ieva Cirule; Mark Vandewalker
Author and Funding Information

University Hospital Carl Gustav Carus, Dresden, Germany


Chest. 2014;146(4_MeetingAbstracts):698A. doi:10.1378/chest.1994562
Text Size: A A A
Published online

Abstract

SESSION TITLE: Childhood Asthma Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PM

PURPOSE: A considerable proportion of adolescent patients (pts) with asthma remain symptomatic despite treatment with currently available therapies. The once-daily long-acting anticholinergic bronchodilator tiotropium Respimat® (tioR) add-on to ICS ± LABA improves lung function in adults with symptomatic asthma. Here we investigate the efficacy, safety, and 24-hour (24-h) bronchodilation of tioR add-on to medium-dose ICS in adolescent pts with symptomatic asthma.

METHODS: This randomized, double-blind, placebo-controlled, incomplete crossover study with 3 × 4-week treatment periods evaluated once-daily tioR 5 µg, 2.5 µg, and 1.25 µg add-on to medium-dose ICS vs placebo Respimat® (pboR) (NCT01122680) in adolescent pts with symptomatic asthma. Main inclusion criteria: aged 12-17 years; symptomatic at screening (seven-question Asthma Control Questionnaire mean score≥1.5); pre-bronchodilator forced expiratory volume in 1 second (FEV1) >60% and ≤90% of predicted. Exclusion criteria: significant respiratory disease other than asthma; exacerbation or acute respiratory infection during the previous 4 weeks. The primary endpoint was peak FEV1(0-3h) response (difference from baseline) at the end of each treatment period. Secondary endpoints included trough FEV1 response, FEV1 area under the curve (AUC) and forced vital capacity (FVC). AUC(0-24h/0-14h/14-24h) responses were also analyzed in a subset of pts (exploratory analysis).

RESULTS: 105 pts were randomized: median age 14 years; 63.8% male. TioR 5 µg provided statistically significant improvement in peak FEV1(0-3h) and trough FEV1 responses vs pboR (adjusted mean of difference ± standard error: 113 ± 39 mL; P=0.0043, and 151 ± 36 mL; P<0.0001, respectively). 49 pts underwent 24-h lung function testing. All doses of tioR improved 24-h bronchodilation compared with pboR when assessed with FEV1 AUC and FVC AUC(0-24h/0-14h/14-24h) responses. The small number of pts in the 24-h lung function subset did not permit rigorous statistical analysis. Adverse events were balanced across treatments groups; no dose-dependency was observed.

CONCLUSIONS: Once-daily tioR 5 µg add-on to medium-dose ICS provides sustained bronchodilation, is well tolerated, and has a safety profile comparable to placebo Respimat® in adolescent pts with symptomatic asthma.

CLINICAL IMPLICATIONS: Once-daily tiotropium Respimat® add-on to medium-dose ICS may provide a potential treatment option for adolescent pts with symptomatic asthma. Funding: Boehringer Ingelheim. Editorial assistance: Complete HealthVizion.

DISCLOSURE: Christian Vogelberg: Grant monies (from industry related sources): Funding in the context as participating study center, Boehringer Ingelheim Michael Engel: Employee: Boehringer-Ingelheim Petra Moroni-Zentgraf: Employee: Boehringer-Ingelheim Ralf Sigmund: Employee: Boehringer-Ingelheim John Downie: Employee: Boehringer-Ingelheim Mark Vandewalker: Grant monies (from industry related sources): Boehringer-Ingelheim The following authors have nothing to disclose: Migle Leonaviciute-Klimantaviciene, Viktorija Vevere, Ieva Cirule

This abstract includes data from a clinical trial of tiotropium in asthma. However, tiotropium is not approved for use in asthma and its safety and efficacy have not yet been established in asthma.


Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
Guidelines
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543