12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

Phase 3

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00239473
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2003-12
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-17
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Trough FEV1 response	after 12 weeks

Secondary Outcome Measures

Name	Time	Method
Trough FEV1 response	after 1, 4 and 8 weeks
Trough FVC response	after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response	after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements	during 12 weeks
Onset and duration of therapeutic response and percentage of responders	after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)	up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)	up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)	up to 15 weeks
Physician's Global Evaluation	up to 15 weeks
Number of patients with at least one exacerbation of COPD	up to 15 weeks
Time to first exacerbation	up to 15 weeks
Number of exacerbations and exacerbation days	up to 15 weeks

Trial Locations

Locations (28)

Ospedale San Giovanni; 🇨🇭 Bellinzona, Switzerland

Kantonsspital St. Gallen; 🇨🇭 St. Gallen, Switzerland

Ospedale Silvestrini; 🇮🇹 San Sisto (pg), Italy

UCT Lung Institute; 🇿🇦 Cape Town, South Africa

U. O. di Fisiopatologia Respiratoria; 🇮🇹 Ferrara, Italy

Ospedale S. Martino; 🇮🇹 Genova, Italy

1 Military Hospital; 🇿🇦 Pretoria, South Africa

Boehringer Ingelheim Investigational Site; 🇨🇭 Münchenstein, Switzerland

Ospedale Generale Provinciale Mazzoni; 🇮🇹 Ascoli Piceno, Italy

Johannes-Gutenberg-Universität Mainz; 🇩🇪 Mainz, Germany

U. O. C di Pneumologia; 🇮🇹 Roma, Italy

U. O. di Pneumologia e Servizio di Fisiopatologia Resp.; 🇮🇹 Milano, Italy

Abt. Lungen- und Bronchialheilkunde; 🇩🇪 Schmallenberg, Germany

Tygerberg Hospital; 🇿🇦 Tygerberg, South Africa

Universitätskliniken Basel; 🇨🇭 Basel, Switzerland

IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

MEDARS GmbH; 🇩🇪 Berlin, Germany

Inamed Research GmbH & Co. KG; 🇩🇪 Gauting, Germany

Pneumologisches Forschungsinstitut GmbH; 🇩🇪 Großhansdorf, Germany

Pneumologisches Forschungsinstitut GmbH am Krankenhaus; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Neurologische Klinik der Otto-von-Guericke-Universität; 🇩🇪 Magdeburg, Germany

ClinPharm International GmbH & Co. KG; 🇩🇪 Leipzig, Germany

Medizinische Klinik III; 🇩🇪 Moers, Germany

Dip. di Medicina Interna e Medicina Specialistica; 🇮🇹 Catania, Italy

U. O. di Pneumologia; 🇮🇹 Trieste, Italy

Hydromed Hospital; 🇿🇦 Bloemfontein, South Africa

Ospedale Regionale; 🇨🇭 Lugano, Switzerland