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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00365560
• Other study ID #: 205.341
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2006
• Last updated: July 10, 2013
• Start date: August 2006

Study information

• Verified date: July 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• tiotropium

• placebo

Locations

Country	Name	City	State
Denmark	Boehringer Ingelheim Investigational Site	Aalborg
Denmark	Boehringer Ingelheim Investigational Site	Aarhus C
Denmark	Boehringer Ingelheim Investigational Site	Hvidovre
Denmark	Boehringer Ingelheim Investigational Site	K?benhavn NV
Denmark	Boehringer Ingelheim Investigational Site	Odense C
Germany	Boehringer Ingelheim Investigational Site	Gelnhausen
Germany	Boehringer Ingelheim Investigational Site	Gro?hansdorf
Germany	Boehringer Ingelheim Investigational Site	Rudersdorf
Germany	Boehringer Ingelheim Investigational Site	Wiesbaden
Germany	Boehringer Ingelheim Investigational Site	Wiesloch
Netherlands	lokatie Langendijk	Breda
Netherlands	Polikliniek longziekten	Eindhoven
Netherlands	Polikliniek longziekten	Groningen
Netherlands	Polikliniek Longziekten	Heerlen
Netherlands	Polikliniek longziekten	Hengelo
Netherlands	lokatie het Spittaal	Zutphen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Denmark,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy endpoint is the FEV1 response (within 3 hours post dosing) determined at the end of the 8-week treatment period
Secondary	FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.

External Links

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