NCT01172821

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat® Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 µg Twice Daily) Over 24 Weeks in Moderate Persistent Asthma

Completed Phase 3 Results posted Last updated 3 June 2014

What this trial tests

Phase 3 trial testing placebo in Asthma in 1,032 participants. Completed in 1 November 2012.

Timeline

1 August 2010

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,032
Start date	1 August 2010
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	125 locations across United States, Brazil, China, Colombia, Germany, India, Japan, Mexico

Drugs / interventions tested

• placebo
• placebo
• placebo
• tiotropium Respimat® low dose — full drug profile →
• placebo
• tiotropium Respimat® high dose — full drug profile →
• 50 mcg salmeterol HFA MDI — full drug profile →
• placebo

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

Adults 18 to 75, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Peak FEV1 Within 3 Hours Post-dose Response
  Time frame: 24 weeks
  Peak forced expiratory volume in one second (FEV1) response within 3 hours post-dose determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
• Trough FEV1 Response
  Time frame: 24 weeks
  Trough FEV1 response determined at the end of the 24-week treatment. Response was defined as change from baseline (10 minutes before the first dose of trial medication at visit 2). Means are adjusted for treatment, centre, week, baseline, treatment by week, and baseline by week.
• The Responder Rate as Assessed by the ACQ From the Two Twin Trials 205.418 (NCT01172808) and the Present 205.419 (NCT01172821)
  Time frame: 24 weeks
  The responder rate as assessed by the Asthma Control Questionnaire (ACQ) determined at the end of the 24-week treatment period (on combined data from the two twin trials 205.418 (NCT01172808) and 205.419 (NCT01172821)). A patient was considered to be a responder if he or she was reported with an improvement (decrease) in the ACQ total score of at least 0.5 points.

Sponsor's own description

The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily). Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of maintenance treatment with inhaled corticosteroid controller medication in patients with moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung function, effects on asthma exacerbations, effects on quality of life, effects on asthma control, effects on health care resource utilisation, and number of adverse events.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials.
   Kerstjens HA, Casale TB, Bleecker ER, Meltzer EO, et al · · 2015 · cited 131× · PMID 25682232 · DOI 10.1016/s2213-2600(15)00031-4
2. Long-Term Once-Daily Tiotropium Respimat® Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study.
   Ohta K, Ichinose M, Tohda Y, Engel M, et al · · 2015 · cited 72× · PMID 25894430 · DOI 10.1371/journal.pone.0124109
3. Tiotropium Respimat® in asthma: a double-blind, randomised, dose-ranging study in adult patients with moderate asthma.
   Beeh KM, Moroni-Zentgraf P, Ablinger O, Hollaenderova Z, et al · · 2014 · cited 62× · PMID 24890738 · DOI 10.1186/1465-9921-15-61
4. Tiotropium Respimat Add-on Is Efficacious in Symptomatic Asthma, Independent of T2 Phenotype.
   Casale TB, Bateman ED, Vandewalker M, Virchow JC, et al · · 2018 · cited 53× · PMID 29174062 · DOI 10.1016/j.jaip.2017.08.037
5. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus the same dose of ICS alone for adults with asthma.
   Anderson DE, Kew KM, Boyter AC. · · 2015 · cited 23× · PMID 26301488 · DOI 10.1002/14651858.cd011397.pub2
6. Long-acting muscarinic antagonists: a potential add-on therapy in the treatment of asthma?
   Busse WW, Dahl R, Jenkins C, Cruz AA. · · 2016 · cited 20× · PMID 26929422 · DOI 10.1183/16000617.0052-2015
7. Long-acting muscarinic antagonists (LAMA) added to inhaled corticosteroids (ICS) versus addition of long-acting beta2-agonists (LABA) for adults with asthma.
   Kew KM, Evans DJ, Allison DE, Boyter AC. · · 2015 · cited 18× · PMID 26031392 · DOI 10.1002/14651858.cd011438.pub2
8. Peak expiratory flow as an endpoint for clinical trials in asthma: a comparison with FEV₁.
   Halpin DMG, Meltzer EO, Pisternick-Ruf W, Moroni-Zentgraf P, et al · · 2019 · cited 17× · PMID 31319851 · DOI 10.1186/s12931-019-1119-6