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

NCT00931385 | Completed Phase 3 Results

• 1 other identifier: 1222.24
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 11

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, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. 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 treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min 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, just prior to administration of the morning dose of randomized treatment. Means are adjusted using a mixed effects model with center, treatment and period as fixed effects and patient within center as random. 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 treatment (baseline) and 12 h 30 min, 13 h, 14 h, 22 h, 23 h, and 23 h 50 min relative to am dose after six weeks of treatment

Secondary Outcomes (10)

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

  1 h and 10 min prior to am dose on the first day of treatment (baseline) and -30 min, 30 min, 60 min, 2h, 3h, 4h, 6h, 8h, 10h, 11 hr 50 min,12 h 30 min, 13 h, 14 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 Six Weeks of Treatment

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

• Peak FEV1 (0-3h) Response

  Baseline and 6 weeks

• Trough FEV1 Response

  Baseline and 6 weeks

• Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response

  1 hour (h) and 10 minutes (min) prior to am dose on the first day of treatment (baseline) and -30 min (zero time), 30 min, 60 min, 2 hour (h) , 3 h, 4 h, 6 h, 8 h, 10 h, 11 h 50 min relative to am dose after six weeks of treatment

Study Arms (4)

BI 1744 (Olodaterol) Low Dose

EXPERIMENTAL

BI1744 Low Dose once daily

Drug: bi1744

BI 1744 (Olodaterol) Med Dose

EXPERIMENTAL

BI 1744 Med Dose once daily

Drug: BI 1744

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Placebo

Foradil

ACTIVE COMPARATOR

Foradil 12 mcg twice daily

Drug: Foradil

Interventions

BI 1744 DRUG

BI1744 Respimat Med Dose Once Daily

BI 1744 (Olodaterol) Med Dose

bi1744 DRUG

1744 low dose

BI 1744 (Olodaterol) Low Dose

Placebo DRUG

Placebo Respimat and Foradil Placebo

Placebo

Foradil DRUG

Foradil 12 mcg twice daily and Placebo Respimat

Foradil

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 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 use
• 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 (11)

1222.24.24011 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1222.24.24009 Boehringer Ingelheim Investigational Site

Overland Park, Kansas, United States

Location

1222.24.24007 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

1222.24.24002 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

1222.24.24010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1222.24.24004 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1222.24.24006 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Location

1222.24.24005 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1222.24.24008 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1222.24.24001 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1222.24.24003 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

Related Publications (1)

• Feldman GJ, Bernstein JA, Hamilton A, Nivens MC, Korducki L, LaForce C. The 24-h FEV1 time profile of olodaterol once daily via Respimat(R) and formoterol twice daily via Aerolizer(R) in patients with GOLD 2-4 COPD: results from two 6-week crossover studies. Springerplus. 2014 Aug 9;3:419. doi: 10.1186/2193-1801-3-419. eCollection 2014.

  PMID: 25187881 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol; Formoterol Fumarate

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)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

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: July 1, 2009
• First Posted: July 2, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05

Locations

US (11)