NCT01126437|CompletedPhase 3Results

Comparison of Tiotropium in the HandiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease

A Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Design, Multi-center Trial to Compare the Efficacy and Safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution Delivered by the Respimat Inhaler With Tiotropium Inhalation Capsules 18 µg Delivered by the HandiHaler (TIOSPIR)

Boehringer Ingelheim ClinicalTrials.gov

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2 other identifiers

205.4522009-015713-51

Study Type

interventional

Target

17,183

Locations

48 countries

Sites

1165

Timeline

RegisteredMay 2010

StartedMay 2010

CompletionMay 2013

Brief Summary

Direct comparison studies of the tiotropium HandiHaler® 18 µg and Respimat® 5 µg formulations have been limited to 4-week crossover studies. Therefore, prospective data from a trial of adequate size and duration is required to establish that compared to tiotropium HandiHaler®, tiotropium Respimat® will have (a) similar effects on safety and (b) similar or superior effects on exacerbations.

Trial Health

On Track

Trial Health Score

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

Strong global presence with extensive site network

Enrollment

17,183

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started May 2010

Typical duration for phase_3

Geographic Reach

48 countries

1165 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

3 years study duration

Study Start

First participant enrolled

May 1, 2010

Completed

5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed

13 days until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

June 20, 2014

Completed

Last Updated

June 20, 2014

Status Verified

May 1, 2014

Enrollment Period

3 years

First QC Date

May 6, 2010

Results QC Date

May 20, 2014

Last Update Submit

May 20, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

Time to All-Cause Mortality
Number of patients with all-cause mortality
Up to 3 years
Time to First COPD Exacerbation
Defined as "a complex of lower respiratory events/symptoms (increase of new onset) related to the underlying COPD, with duration of three days or more, requiring a change in treatment" where a "complex of lower respiratory event/symptoms" was defined as having at least two of the following: shortness of breath, sputum production (volume), occurrence of purulent sputum, cough, wheezing, chest tightness and where "a required change in treatment" includes the following:Prescription of antibiotics and/or systemic steroids, and/or a newly prescribed maintenance respiratory medication (i.e., bronchodilators including theophyllines). "Onset of exacerbation" was defined by the onset of first recorded symptom. The "end of exacerbation" was decided by the investigator based on clinical judgement. Exacerbations were classified as follows: Mild:a new prescription of maintenance bronchodilator only Moderate:antibiotics or systemic steroids without hospitalization Severe:hospitalization.
Up to 3 years

Secondary Outcomes (7)

Trough FEV1 Over 120 Weeks (in a Substudy of 1370 Patients)
Up to 3 years
Number of COPD Exacerbations
Up to 3 years
Time to First Hospitalization Associated With COPD Exacerbation
Up to 3 years
Number of Hospitalizations Associated With COPD Exacerbation
Up to 3 years
Time to First Moderate to Severe COPD Exacerbation
Up to 3 years
+2 more secondary outcomes

Study Arms (3)

tiotropium 2.5 mcg and placebo

EXPERIMENTAL

Patients receive one of the active tiotropium arms daily

Drug: tiotropium 1.25 mcg (2 actuations/day)

tiotropium 18 mcg and placebo

ACTIVE COMPARATOR

Patients receive one of the active tiotropium arms daily

Drug: tiotropium 18 mcg

tiotropium 5 mcg and placebo

EXPERIMENTAL

Patients receive one of the active tiotropium arms daily

Drug: tiotropium 2.5 mcg (2 actuations/day)

Interventions

tiotropium 18 mcgDRUG

HandiHaler

tiotropium 18 mcg and placebo

tiotropium 1.25 mcg (2 actuations/day)DRUG

soft mist inhaler 2 actuations=2 puffs/day

tiotropium 2.5 mcg and placebo

tiotropium 2.5 mcg (2 actuations/day)DRUG

soft mist inhaler (2 actuations=2 puffs/day)

tiotropium 5 mcg and placebo

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

All patients must sign an informed consent consistent with International Conference on Harmonization Good Clinical Practice (ICH-GCP) guidelines prior to participation in the trial, which includes medication washout and restrictions.
Male or female patients 40 years of age or older.
Patients must be current or ex-smokers with a smoking history of ≥10 pack-years. (Patients who have never smoked cigarettes must be excluded)
All patients must have a diagnosis of COPD (P06-12085), and must meet the following criteria: Relatively stable airway obstruction with a post-bronchodilator FEV1 ≤ 70% of predicted normal and post-bronchodilator FEV1 / FVC ≤70%.
Pulmonary function tests (PFTs) were conducted after the inhalation of 400 μg salbutamol / albuterol (preferred), however testing with either 200 μg salbutamol/albuterol or a combination of salbutamol / albuterol with ipratropium bromide (2 to 4 actuations) was acceptable. Other short-acting beta agonists, such as terbutaline, may have been used for the testing. The medication used for the testing was documented. Further, historical data from measurements within the past 6 months either at the site or at a referral site may have been used (see Section 6.2.1 of the CTP, located in Appendix 16.1.1). Subjects were not to have been randomized to the study without the availability of spirometry data at the actual study site.
Able to inhale from the HandiHaler® and the Respimat® devices.

You may not qualify if:

Significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence the patients ability to participate in the study.
Patients with a recent history (i.e., six months or less) of myocardial infarction.
Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year.
Hospitalisation for cardiac failure (New York Heart Association (NYHA) Class III or IV) during the past year.
Known active tuberculosis.
Patients with a history of asthma, cystic fibrosis, clinically evident bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease.
Subject was planning to undergo lung transplant or lung volume reduction surgery (LVRS).
Malignancy for which the subject had undergone resection, radiation, chemotherapy or biological treatments within the last 5 years. Subjects with treated basal cell carcinoma were allowed.
Known respiratory infection or exacerbation of COPD in the 4 weeks prior to randomization.
Known hypersensitivity to anticholinergic drugs, lactose, benzalkonium chloride (BAC), ethylenediaminetetraacetic acid (EDTA), or any other components of the HandiHaler® or Respimat® inhalation solution delivery system.
Known moderate to severe renal impairment (as judged by the investigator).
Known narrow angle glaucoma.
Known significant symptomatic prostatic hyperplasia or bladder-neck obstruction. Subjects whose symptoms were controlled on treatment may have been included.
Use of systemic corticosteroid medication at unstable doses (i.e., less than 6 weeks on stable dose) or at doses in excess of the equivalent of 10 mg prednisolone per day.
Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception for at least 3 months prior to and for the duration of the trial.
+6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Boehringer Ingelheimlead

Study Sites (1191)

205.452.01107 Boehringer Ingelheim Investigational Site

Athens, Alabama, United States

Location

205.452.01023 Boehringer Ingelheim Investigational Site