MedDataX Logo

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

NCT ID: NCT00931385

Last Updated: 2014-07-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

NCT00932646

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

NCT00793624

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II

NCT00796653

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

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

NCT01040689

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD

NCT00846768

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BI 1744 (Olodaterol) Low Dose

BI1744 Low Dose once daily

Group Type EXPERIMENTAL

bi1744

Intervention Type DRUG

1744 low dose

BI 1744 (Olodaterol) Med Dose

BI 1744 Med Dose once daily

Group Type EXPERIMENTAL

BI 1744

Intervention Type DRUG

BI1744 Respimat Med Dose Once Daily

Placebo

Placebo once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Respimat and Foradil Placebo

Foradil

Foradil 12 mcg twice daily

Group Type ACTIVE_COMPARATOR

Foradil

Intervention Type DRUG

Foradil 12 mcg twice daily and Placebo Respimat

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BI 1744

BI1744 Respimat Med Dose Once Daily

Intervention Type DRUG

bi1744

1744 low dose

Intervention Type DRUG

Placebo

Placebo Respimat and Foradil Placebo

Intervention Type DRUG

Foradil

Foradil 12 mcg twice daily and Placebo Respimat

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 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 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
* those who are not willing to comply with pulmonary medication washouts
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boehringer Ingelheim

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1222.24.24011 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1222.24.24009 Boehringer Ingelheim Investigational Site

Overland Park, Kansas, United States

Site Status

1222.24.24007 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

1222.24.24002 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1222.24.24010 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1222.24.24004 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1222.24.24006 Boehringer Ingelheim Investigational Site

Gaffney, South Carolina, United States

Site Status

1222.24.24005 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1222.24.24008 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1222.24.24001 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1222.24.24003 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25187881 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1222.24

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040728 COMPLETED PHASE3
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
NCT01113593 COMPLETED PHASE2
12 / 48 wk Pivotal PFT vs PBO in COPD II
NCT00782509 COMPLETED PHASE3
12 / 48 Week Pivotal PFT vs PBO in COPD I
NCT00782210 COMPLETED PHASE3
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
NCT01040793 COMPLETED PHASE3
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
NCT00452400 COMPLETED PHASE2
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
NCT01040130 COMPLETED PHASE3
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease
NCT01323634 COMPLETED PHASE3
Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01323621 COMPLETED PHASE3
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
NCT01794780 COMPLETED PHASE4
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
NCT01809262 COMPLETED PHASE2
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT01574651 COMPLETED PHASE3
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01168310 COMPLETED PHASE2
A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.
NCT01013753 COMPLETED PHASE2
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
NCT01033487 COMPLETED PHASE2
A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo
NCT01072149 COMPLETED PHASE3
A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))
NCT01342913 COMPLETED PHASE3
Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Risk for Co-morbid Cardiovascular Disease
NCT01627327 COMPLETED PHASE3
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00720499 COMPLETED PHASE2
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD
NCT00824382 COMPLETED PHASE2
Lung Function Changes Following the Addition of Formoterol to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02242240 COMPLETED PHASE2
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01085045 COMPLETED PHASE2
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
NCT01043601 WITHDRAWN PHASE2
Pharmacokinetics of CHF 5993 pMDI With and Without Spacer in COPD Patients
NCT02119234 COMPLETED PHASE1
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
NCT00783406 COMPLETED PHASE2