Clinical trial NCT00365560: An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: 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:
measure: FEV1 and FVC AUC 0-3h (in a subset 0-24h) PEF, use of rescue medication, daytime and nocturnal symptoms etc.
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Aarhus C
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: K?benhavn NV
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Odense C
country: Denmark
facility: Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Gro?hansdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Rudersdorf
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesbaden
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: lokatie Langendijk
city: Eindhoven
country: Netherlands
facility: Polikliniek longziekten
city: Groningen
country: Netherlands
facility: Polikliniek longziekten
city: Heerlen
country: Netherlands
facility: Polikliniek Longziekten
city: Hengelo
country: Netherlands
facility: Polikliniek longziekten
city: Zutphen
country: Netherlands
facility: lokatie het Spittaal
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim Study Coordinator
role: STUDY_CHAIR
References:
citation: 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.