Comparison of Tiotropium in the HandhiHaler Versus the Respimat in Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01126437

Purpose

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.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium 18 mcg Drug: tiotropium 1.25 mcg Drug: tiotropium 2.5 mcg	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Tiotropium bromide

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Time to first COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Time to death . [ Time Frame: 24 monhts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to first hospitalization due to COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Number of hospitalizations due to COPD exacerbation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Time to first major adverse cardiovascular event [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Number of COPD exacerbations [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	17182
Study Start Date:	May 2010
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: tiotropium 2.5 mcg and placebo Patients receive one of the active tiotropium arms daily	Drug: tiotropium 1.25 mcg soft mist inhaler
Active Comparator: tiotropium 18 mcg and placebo Patients receive one of the active tiotropium arms daily	Drug: Tiotropium 18 mcg HandiHaler
Experimental: tiotropium 5 mcg and placebo Patients receive one of the active tiotropium arms daily	Drug: tiotropium 2.5 mcg soft mist inhaler

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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 less than 70% of predicted normal and post-bronchodilator FEV1 / FVC less than 70%

Exclusion criteria:

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, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126437

Show 1193 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01126437 History of Changes
Other Study ID Numbers:	205.452, 2009-015713-51
Study First Received:	May 6, 2010
Last Updated:	May 2, 2012
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Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012