NCT00274573|CompletedPhase 3

Effects of Once Daily Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

Acute and Long-term Effects of Once Daily Oral Inhalation of Tiotropium 18 Mcg Dry Powder Inhalation Capsules in a Placebo Controlled Parallel Group Design Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) of Different Severity

Boehringer Ingelheim ClinicalTrials.gov

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1 other identifier

205.257

Study Type

interventional

Target

1,639

Locations

1 country

Sites

177

Timeline

RegisteredJan 2006

StartedMar 2002

Brief Summary

The primary objective of this study is to investigate the effect of tiotropium vs. placebo on trough FEV1 and FEV1 2 hours post inhalation after 12 weeks of treatment. For both endpoints changes from baseline will be analysed. Three strata of patients will be included (severe COPD, i.e. \<35% of predicted FEV1, moderate COPD, i.e. 35% - \<50% of predicted FEV1, mild COPD, i.e. 50% - 70% of predicted FEV1, according to American Thoracic Society \[ATS\] criteria). The study is conducted in order to find out for which endpoint tiotropium is different from placebo in which stratum.

Trial Health

On Track

Trial Health Score

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

Enrollment

1,639

participants targeted

Target at P75+ for phase_3

Geographic Reach

1 country

177 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2002

Completed

3.3 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed

2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed

Last Updated

November 21, 2013

Status Verified

November 1, 2013

Enrollment Period

7 months

First QC Date

January 9, 2006

Last Update Submit

November 20, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

Change from baseline in trough FEV1 (Forced expiratory volume in one second)
after 12 weeks
Change from baseline in FEV1 2 hours post inhalation
after 12 weeks

Secondary Outcomes (9)

Change from baseline in FEV1 2 hours post inhalation
Day 1
Change from baseline in FVC (Forced Vital Capacity) 2 hours post inhalation
Day 1 and 85
Change from baseline in IVC (Inspiratory Vital Capacity) 2 hours post inhalation
Day 1 and 85
Number of patients having a COPD exacerbation
12 weeks
Number of patients being hospitalised due to a COPD exacerbation
12 weeks
+4 more secondary outcomes

Interventions

Tiotropium bromideDRUG

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable, mild to severe airway obstruction with an FEV1 =\<70% of predicted normal and an FEV1/FVC \< 70 %.
Predicted normal values will be taken from the print-outs of the spirometers. Spirometers have to calibrated according to ECCS.
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of 10 or more than 10 pack-years. Pack Years = Number of cigarettes/day : 20 x years of smoking (Patients who have never smoked cigarettes must not be included)
Patients must be able to perform all study related tests, acceptable pulmonary function tests, including Peak Expiratory Flow Rate (PEFR) measurements, and must be able to maintain diary cards during the study period as required in the protocol.
Patients must be able to inhale medication from the HandiHaler.
All patients must sign an Informed Consent Form prior to participation in the trial i.e. prior to pre-study washout of their usual pulmonary medications.

You may not qualify if:

Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
Patients with a recent history (i.e., one year or less) of myocardial infarction.
Patients with any cardiac arrhythmia requiring drug therapy or who have been hospitalised for heart failure within the past three years.
Patients who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy.
Patients with known active tuberculosis.
Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
Patients with any respiratory infection in the past six weeks prior to the Screening Visit (Visit 1) or during the run-in period.
Patients who are currently in a pulmonary rehabilitation programme or who have completed a pulmonary rehabilitation programme in the six week prior to the Screening Visit (Visit 1).
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system.
Patients with known symptomatic prostate hypertrophy or bladder neck obstruction.
Patients with known narrow-angle glaucoma.
Patients using oral corticosteroid medication at unstable doses (i.e., less than four weeks on a stable dose before Visit 1) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day.
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or subdermal implants).
Patients with a history of asthma, allergic rhinitis or atopy.
+1 more criteria

Contact the study team to confirm eligibility.