NCT00932646

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

13 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

Study Start

First participant enrolled

June 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 3, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 27, 2014

Completed
Last Updated

February 5, 2016

Status Verified

January 1, 2016

Enrollment Period

11 months

First QC Date

July 2, 2009

Results QC Date

March 28, 2014

Last Update Submit

January 11, 2016

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 the 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 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

  • +5 more secondary outcomes

Study Arms (4)

BI1744 (Olodaterol)

EXPERIMENTAL

Medium Dose once Daily

Drug: BI 1744 (Olodaterol) Medium Dose

BI 1744 (Olodaterol)

EXPERIMENTAL

Low Dose once Daily

Drug: BI 1744 (Olodaterol) Low Dose

Placebo

PLACEBO COMPARATOR

Placebo once Daily

Drug: Placebo

Foradil

ACTIVE COMPARATOR

12 mcg twice daily

Drug: Foradil

Interventions

BI 1744 (Olodaterol) Low DoseDRUG

BI1744 Respimat low dose once daily and placebo Foradil

BI 1744 (Olodaterol)
BI 1744 (Olodaterol) Medium DoseDRUG

BI1744 Respimat medium dose once daily and placebo Foradil

BI1744 (Olodaterol)
PlaceboDRUG

Placebo Respimat once daily and placebo Foradil

Placebo
ForadilDRUG

12 mcg twice daily and placebo Respimat

Foradil

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

1222.25.25009 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1222.25.25002 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1222.25.25003 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1222.25.25007 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1222.25.25010 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Location

1222.25.25008 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1222.25.25012 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1222.25.25004 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1222.25.25011 Boehringer Ingelheim Investigational Site

Columbus, Ohio, United States

Location

1222.25.25014 Boehringer Ingelheim Investigational Site

Seneca, South Carolina, United States

Location

1222.25.25006 Boehringer Ingelheim Investigational Site

Knoxville, Tennessee, United States

Location

1222.25.25005 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1222.25.25013 Boehringer Ingelheim Investigational Site

Richmond, Virginia, 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: 25187881DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterolFormoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Limitations and Caveats

1. Safety assessments are potentially confounded by both crossover and long washout periods 2. Comparisons of active groups for the 12 to 24 hr period overestimate the effect of Foradil (sleeping period causing an overestimation of AUC)

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 3, 2009

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Last Updated

February 5, 2016

Results First Posted

June 27, 2014

Record last verified: 2016-01

Locations

US(13)