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Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma II

NCT01172821 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1032

Last updated 2014-06-09

Study results available
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Summary

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.

Conditions

Interventions

DRUG

placebo

Placebo that represents BI drug

DRUG

placebo

Placebo that represents comparator

DRUG

placebo

Placebo that represents comparator

DRUG

tiotropium Respimat® low dose

IMP

DRUG

placebo

Placebo that represents BI drug

DRUG

tiotropium Respimat® high dose

IMP

DRUG

50 mcg salmeterol HFA MDI

Active comparator

DRUG

placebo

Placebo that represents comparator

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States
  • Brazil
  • China
  • Colombia
  • Germany
  • India
  • Japan
  • Mexico
  • Peru
  • Poland
  • Romania

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01172821 on ClinicalTrials.gov