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

NCT ID: NCT00365560

Last Updated: 2013-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

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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

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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tiotropium

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

Aarhus C, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

K?benhavn NV, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Gro?hansdorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Rudersdorf, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wiesbaden, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

lokatie Langendijk

Breda, , Netherlands

Site Status

Polikliniek longziekten

Eindhoven, , Netherlands

Site Status

Polikliniek longziekten

Groningen, , Netherlands

Site Status

Polikliniek Longziekten

Heerlen, , Netherlands

Site Status

Polikliniek longziekten

Hengelo, , Netherlands

Site Status

lokatie het Spittaal

Zutphen, , Netherlands

Site Status

Countries

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Denmark Germany Netherlands

References

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Kerstjens HA, Disse B, Schroder-Babo W, Bantje TA, Gahlemann M, Sigmund R, Engel M, van Noord JA. Tiotropium improves lung function in patients with severe uncontrolled asthma: a randomized controlled trial. J Allergy Clin Immunol. 2011 Aug;128(2):308-14. doi: 10.1016/j.jaci.2011.04.039. Epub 2011 Jun 2.

Reference Type DERIVED
PMID: 21636120 (View on PubMed)

Other Identifiers

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205.341

Identifier Type: -

Identifier Source: org_study_id

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