NCT00365560|CompletedPhase 2

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

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

205.341

Study Type

interventional

Target

115

Locations

3 countries

Sites

Timeline

RegisteredAug 2006

StartedAug 2006

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

115

participants targeted

Target at P50-P75 for phase_2 asthma

Geographic Reach

3 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed

15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2006

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed

Last Updated

July 11, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

August 16, 2006

Last Update Submit

July 10, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

tiotropiumDRUG

placeboDRUG

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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)

Contact the study team to confirm eligibility.