Clinical trial NCT00931385: Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
Official title: Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil Iin Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 99
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 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 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

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 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
measure: FEV1 Area Under Curve 12-24h (AUC 12-24h) Response After Six Weeks of Treatment
timeFrame: 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:
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 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.
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 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
measure: Peak FEV1 (0-3h) Response
timeFrame: Baseline and 6 weeks
measure: Trough FEV1 Response
timeFrame: 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 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
measure: FVC Area Under Curve 12-24 Hours (AUC 12-24h) Response
timeFrame: 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
measure: FVC Area Under Curve 0-24 Hours (AUC 0-24h) Response
timeFrame: 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.
measure: Peak FVC (0-3h) Response
timeFrame: Baseline and 6 weeks
measure: Trough FVC Response
timeFrame: Baseline and 6 weeks
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: 1222.24.24011 Boehringer Ingelheim Investigational Site
state: Florida
city: Overland Park
country: United States
facility: 1222.24.24009 Boehringer Ingelheim Investigational Site
state: Kansas
city: Lafayette
country: United States
facility: 1222.24.24007 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Cincinnati
country: United States
facility: 1222.24.24002 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1222.24.24010 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Easley
country: United States
facility: 1222.24.24004 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Gaffney
country: United States
facility: 1222.24.24006 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1222.24.24005 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1222.24.24008 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1222.24.24001 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Union
country: United States
facility: 1222.24.24003 Boehringer Ingelheim Investigational Site
state: South Carolina
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.