NCT00168831|CompletedPhase 3Results

Tiotropium / Respimat One-Year Study

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

205.255

Study Type

interventional

Target

1,007

Locations

14 countries

Sites

Timeline

RegisteredSep 2005

StartedFeb 2003

Brief Summary

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,007

participants targeted

Target at P75+ for phase_3

Geographic Reach

14 countries

70 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

February 1, 2003

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed

4.1 years until next milestone

Results Posted

Study results publicly available

October 7, 2009

Completed

Last Updated

May 20, 2014

Status Verified

September 1, 2013

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Results QC Date

January 30, 2009

Last Update Submit

May 15, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (4)

Change From Baseline in Trough FEV1 After 48 Weeks
Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks
10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication
Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)
Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0
Week 48
TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)
Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.
Week 48
COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)
Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.
48 weeks

Secondary Outcomes (54)

Change From Baseline in Heart Rate
Baseline to Week 40 pre-dose
Change From Baseline in PR Interval
Baseline to Week 40 pre-dose
Change From Baseline in QRS Interval
Baseline to Week 40 pre-dose
Change From Baseline in QT Interval
Baseline to Week 40 pre-dose
Change From Baseline in QT Interval (Bazett)
Baseline to Week 40 pre-dose
+49 more secondary outcomes

Study Arms (3)

Tiotropium Respimat 5mcg (Tio R5)

OTHER

Drug: Tiotropium Inhalation Solution

Tiotropium Respimat 10mcg (Tio R10)

OTHER

Drug: Tiotropium Inhalation Solution

Placebo

OTHER

Other: Placebo

Interventions

Tiotropium Inhalation SolutionDRUG

Tiotropium Respimat 10mcg (Tio R10)Tiotropium Respimat 5mcg (Tio R5)

PlaceboOTHER

Placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

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

Criteria * Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.