Clinical trial NCT01040728: 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
Official title: Randomised, Double-blind, Double-dummy, Placebo-controlled, 4-way Cross-over Study to Characterise the 24-hour 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-12-30
Enrollment: 122
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is intended to characterize the lung function profile of BI1744 in Chronic Obstructive Pulmonary Disease (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.


Eligibility 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

Primary outcomes:
measure: FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After Six Weeks of Treatment
timeFrame: 1 hour (h) and 10 minutes (min) prior to the 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
measure: FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
timeFrame: 1 h and 10 min prior to the 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:
measure: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-24 h (AUC 0-24h) Response After Six Weeks of Treatment
timeFrame: 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
measure: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After First Dose of Treatment
timeFrame: 1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment period
measure: Forced Expiratory Volume in 1 Second (FEV1) Area Under Curve 0-3 h (AUC 0-3h) Response After Six Weeks of Treatment
timeFrame: 1 hour (h) prior and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h , 3 h, relative to the first dose of treatment after six weeks of treatment
measure: Peak FEV1 (0-3h) Response
timeFrame: Study baseline and first day of dosing
measure: Peak FEV1 (0-3h) Response
timeFrame: Study baseline and 6 weeks
measure: Trough FEV1 Response
timeFrame: Study baseline and 6 weeks
measure: Forced Vital Capacity (FVC) Area Under Curve 0-12 Hours (AUC 0-12h) Response
timeFrame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min (zero time), 30 min, 60 min, 2 h, 3 h, 4 h, 6 h, 8 h, 10 h, 12h relative to last dose after six weeks of treatment.
measure: FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
timeFrame: 1 h and 10 min prior to the 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 last dose after six weeks of treatment
measure: FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
timeFrame: 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 last dose after six weeks of treatment
measure: FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
timeFrame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to first dose of treatment
measure: FVC Area Under Curve 0-3 Hours (AUC 0-3h) Response
timeFrame: 1 hour (h) and 10 minutes (min) prior to the am dose on the first day of the first treatment period (study baseline) and -30 min, 30 min, 60 min, 2 h, 3 h relative to last dose of treatment after six weeks of treatment
measure: Peak FVC (0-3h) Response
timeFrame: Study baseline and 6 weeks
measure: Trough FVC Response
timeFrame: Study baseline and 6 weeks
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 1222.40.11003 Boehringer Ingelheim Investigational Site
state: Alabama
city: Clearwater
country: United States
facility: 1222.40.11001 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1222.40.11002 Boehringer Ingelheim Investigational Site
state: Florida
city: Berlin
country: Germany
facility: 1222.40.49401 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1222.40.49403 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1222.40.49402 Boehringer Ingelheim Investigational Site
city: Breda
country: Netherlands
facility: 1222.40.31003 Boehringer Ingelheim Investigational Site
city: Eindhoven
country: Netherlands
facility: 1222.40.31002 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1222.40.31001 Boehringer Ingelheim Investigational Site
city: Arendal
country: Norway
facility: 1222.40.47003 Boehringer Ingelheim Investigational Site
city: Drammen
country: Norway
facility: 1222.40.47002 Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: 1222.40.47001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: