Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Purpose

The study is intended to characterize the lung function profile of BI1744 in COPD patients where patients will perform pulmonary function tests at regular intervals for 24 hours at the end of a 6 week treatment period. Each patient will receive all four treatments.

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Olodaterol (BI1744) Low Drug: Placebo (for olodaterol BI1744) Drug: Placebo (for Tiotropium) Drug: Olodaterol (BI1744) High Drug: Tiotropium 18 mcg	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour Forced, Expiratory Volume After 1 Second (FEV1) Time Profiles of BI 1744 CL 5µg and 10µg (Oral Inhalation, Delivered by the Respimat® Inhaler) and Tiotropium Bromide 18µg (Oral Inhalation, Delivered by the HandiHaler®) After 6 Weeks of Treatment in Patients With Chronic Obstructive Pulmonary Disease (COPD)

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:

The primary objective will be to evaluate whether once daily treatment with low or high dose Olodaterol (BI 1744) administered via Respimat device is superior to once daily treatment with Placebo using FEV1 AUC12-24 responses after 6 weeks of treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The co-primary efficacy endpoints are FEV1 AUC 0-12 response and FEV1 AUC12-24 response after 6 weeks of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The key secondary objective will be to compare once daily treatment with low or high dose Odolaterol ( BI 1744) administered via the Respimat device to once daily treatment with tiotropium bromide (18mcg handihaler) using FEV1 AUC values. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
FEV1 AUC0-24 response after 6 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
FVC AUC0-12, FVC AUC12-24 and FVC AUC0-24 responses after 6 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Trough FEV1 and FVC responses after 6 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
FEV1 AUC0-3 and FVC AUC0-3 responses after 1st dose and after 6 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Peak FEV1 and FVC responses after 1st dose and after 6 weeks treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Individual FEV1 and FVC measurements at each time point after 1st dose (up to 3 hrs) and after 6 weeks (over 24 hrs) of treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Adverse events; vital signs: pulse rate and blood pressure (seated); Routine blood chemistry, haematology and urinalysis and 12-lead ECG [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	108
Study Start Date:	January 2010
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo olodaterol placebo and/or Tiotropium placebo inhaled once daily	Drug: Placebo (for olodaterol BI1744) Placebo (olodaterol low and high dose)delivered by Respimat Drug: Placebo (for Tiotropium) Placebo (Tiotropium 18 mcg) delivered by HandiHaler
Experimental: Olodaterol (BI1744) Low Low dose inhaled orally once daily from Respimat inhaler	Drug: Olodaterol (BI1744) Low Low dose inhaled orally once daily from Respimat inhaler
Experimental: Olodaterol (BI1744) High High dose inhaled orally once daily from Respimat inhaler	Drug: Olodaterol (BI1744) High High dose inhaled orally once daily from Respimat inhaler
Active Comparator: Tiotropium 18 mcg 18mcg inhaled once daily from Handihaler	Drug: Tiotropium 18 mcg 18mcg inhaled once daily from Handihaler

Eligibility

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

Criteria

Inclusion criteria:

Patients willing to participate with confirmed diagnosis of COPD
40 years of age or older
having a 10 pack year smoking history
able to perform serial pulmonary function tests
able to use both a Dry powder inhaler (DPI) and Respimat device

Exclusion criteria:

Significant other disease
clinically relevant abnormal hematology, chemistry, or urinalysis
history of asthma
diagnosis of thyrotoxicosis
paroxysmal tachycardia related to beta agonists
history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure within 1 year
active tuberculosis, cystic fibrosis, clinically evident bronchiectasis
significant alcohol or drug abuse
pulmonary resection
taking oral beta adrenergics
taking unstable oral steroids
daytime oxygen
enrolled in rehabilitation program
enrolled in another study or taking investigational products
pregnant or nursing women, women of child bearing potential not willing to use two methods of birth control
those who are not willing to comply with pulmonary medication washouts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01040689

Locations

Belgium
1222.39.32003 Boehringer Ingelheim Investigational Site
Genk, Belgium
1222.39.32001 Boehringer Ingelheim Investigational Site
Gent, Belgium
1222.39.32002 Boehringer Ingelheim Investigational Site
Hasselt, Belgium
Denmark
1222.39.45001 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1222.39.45003 Boehringer Ingelheim Investigational Site
Kolding, Denmark
1222.39.45002 Boehringer Ingelheim Investigational Site
Odense C, Denmark
Germany
1222.39.49391 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.39.49392 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1222.39.49393 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Hungary
1222.39.36006 Boehringer Ingelheim Investigational Site
Deszk, Hungary
1222.39.36004 Boehringer Ingelheim Investigational Site
Farkasgyepü, Hungary
1222.39.36005 Boehringer Ingelheim Investigational Site
Pecs, Hungary
1222.39.36003 Boehringer Ingelheim Investigational Site
Szarvas, Hungary
1222.39.36001 Boehringer Ingelheim Investigational Site
Szeged, Hungary
1222.39.36002 Boehringer Ingelheim Investigational Site
Törökbalint, Hungary

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT01040689 History of Changes
Other Study ID Numbers:	1222.39, 2009-014417-27
Study First Received:	December 29, 2009
Last Updated:	May 4, 2011
Health Authority:	Belgium: Federal Agency for Medicinal and Health Products Denmark: Danish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy

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, 2013