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

NCT01040689 | Completed Phase 3 Results

• 2 other identifiers: 1222.392009-014417-27
• Study Type: interventional
• Target: 108
• Locations: 4 countries
• Sites: 15

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment

  Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 12 h relative to am dose after six weeks of treatment

• FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment

  Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed in the morning of the first treatment visit for the first period, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with treatment and period as fixed effects and patient as a random effect and study baseline as a continuous covariate. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  1 h and 10 min prior to am dose on the first day of the first treatment period (study baseline) and 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

Secondary Outcomes (14)

• Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment

  1 hour (h) and 10 minutes (min) prior to am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h, 4 h, 6h, 8h, 10h, 12 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

• Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment

  1 hour (h) prior and 10 minutes (min) prior to first dose of the first period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period

• Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment

  1 hour (h) prior and 10 minutes (min) prior to first dose of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the last dose of treatment after six weeks of treatment.

• Peak FEV1 (0-3h) Response

  Study baseline and first day of dosing

• Peak FEV1 (0-3h) Response

  Study baseline and 6 weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

olodaterol placebo and/or Tiotropium placebo inhaled once daily

Drug: Placebo (for olodaterol BI1744); Drug: Placebo (for Tiotropium)

Olodaterol (BI1744) Low

EXPERIMENTAL

Low dose inhaled orally once daily from Respimat inhaler

Drug: Olodaterol (BI1744) Low

Olodaterol (BI1744) High

EXPERIMENTAL

High dose inhaled orally once daily from Respimat inhaler

Drug: Olodaterol (BI1744) High

Tiotropium 18 mcg

ACTIVE COMPARATOR

18mcg inhaled once daily from Handihaler

Drug: Tiotropium 18 mcg

Interventions

Olodaterol (BI1744) Low DRUG

Low dose inhaled orally once daily from Respimat inhaler

Olodaterol (BI1744) Low

Placebo (for olodaterol BI1744) DRUG

Placebo (olodaterol low and high dose)delivered by Respimat

Placebo

Placebo (for Tiotropium) DRUG

Placebo (Tiotropium 18 mcg) delivered by HandiHaler

Placebo

Olodaterol (BI1744) High DRUG

High dose inhaled orally once daily from Respimat inhaler

Olodaterol (BI1744) High

Tiotropium 18 mcg DRUG

18mcg inhaled once daily from Handihaler

Tiotropium 18 mcg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients willing to participate with confirmed diagnosis of COPD
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (15)

1222.39.32003 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1222.39.32001 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1222.39.32002 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1222.39.45001 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1222.39.45003 Boehringer Ingelheim Investigational Site

Kolding, Denmark

Location

1222.39.45002 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1222.39.49391 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.39.49392 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1222.39.49393 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1222.39.36006 Boehringer Ingelheim Investigational Site

Deszk, Hungary

Location

1222.39.36004 Boehringer Ingelheim Investigational Site

Farkasgyepü, Hungary

Location

1222.39.36005 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

1222.39.36003 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

Location

1222.39.36001 Boehringer Ingelheim Investigational Site

Szeged, Hungary

Location

1222.39.36002 Boehringer Ingelheim Investigational Site

Törökbálint, Hungary

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 29, 2009
• First Posted: December 30, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Last Updated: June 30, 2014
• Results First Posted: June 30, 2014

Record last verified: 2014-05

Locations

DK (3); DE (3); HU (6); BE (3)