An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma

A Randomised, Double-Blind, Placebo-Controlled, Crossover Efficacy and Safety Evaluation of 8-Week Treatment Periods of Two Doses [5 Mcg (2 Actuations of 2.5 Mcg) and 10 Mcg (2 Actuations of 5 Mcg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler® as Add-on Therapy in Patients With Severe Persistent Asthma

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00365560

Enrollment

115

Registered

2006-08-17

Start date

2006-08-31

Completion date

Unknown

Last updated

2013-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification

Interventions

DRUGtiotropium

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Outpatients of either sex, age 18 - 75 years, with at least a documented 5 year history of asthma, and a current diagnosis of severe, persistent asthma (GINA step 4), smoking history \< 10 pack years and \>= 1 year smoking cessation; Patients must be symptomatic

Exclusion criteria

Patients * with a recent history (i.e., six months or less) of myocardial infarction, * who have been hospitalized for heart failure (NYHA class III or IV) within the past year, * with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year, * with malignancy for which the patient has undergone resection, radiation ther apy or chemotherapy within the last five years, * who have undergone thoracotomy with pulmonary resection, * with moderate to severe renal impairment (creatinine clearance = 50 mL/min)

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period	—

Secondary

Measure	Time frame
FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.	—

Countries

Denmark, Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026