Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT00720499 | Completed Phase 2 Results

• 2 other identifiers: 1237.9EudtaCT No: 2008-000562-23
• Study Type: interventional
• Target: 141
• Locations: 4 countries
• Sites: 24

Brief Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.

  Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).

  1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29

Secondary Outcomes (28)

• Trough FEV1 Response [L] After 2 Weeks of Treatment

  1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15

• Individual FEV1 Measurements

  1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29

• FEV1 AUC 0-3h, Response

  1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29

• FEV1 Peak 0-3h Response

  1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29

• FEV1, AUC (0-6h) Response

  1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29

Study Arms (2)

BI 1744 CL low dose+tiotropium bromide

EXPERIMENTAL

BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Drug: BI 1744 CL plus tiotropium bromide; Device: Respimat® Inhaler

BI 1744 CL medium dose+tiotropium bromide

EXPERIMENTAL

BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

Drug: BI 1744 CL plus tiotropium bromide; Device: Respimat® Inhaler

Interventions

BI 1744 CL plus tiotropium bromide DRUG

BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation

BI 1744 CL low dose+tiotropium bromide; BI 1744 CL medium dose+tiotropium bromide

Respimat® Inhaler DEVICE

BI 1744 CL low dose+tiotropium bromide; BI 1744 CL medium dose+tiotropium bromide

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
• All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
• Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \>= 30% of predicted normal and \<80% of predicted normal and a post-bronchodilator FEV1 / FVC \<70% at Visit 1
• Male or female patients, 40 years of age or older
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years
• Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
• Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).

You may not qualify if:

• Patients with a significant disease other than COPD
• Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
• Patients with a history of asthma or a total blood eosinophil count \>= 600/mm3.
• Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (\>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF\* interval \> 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
• Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
• Patients who have undergone thoracotomy with pulmonary resection
• Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
• Pregnant or nursing women
• Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
• Patients who have previously been randomized in this study or are currently participating in another study
• Patients who are unable to comply with pulmonary medication restrictions prior to randomization
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (24)

1237.9.00152 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1237.9.00155 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1237.9.00151 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1237.9.00154 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1237.9.00153 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1237.9.03253 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1237.9.03255 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1237.9.03254 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1237.9.03251 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1237.9.03252 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1237.9.00255 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1237.9.00251 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1237.9.00252 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1237.9.00254 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1237.9.00253 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Location

1237.9.04952 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.9.04953 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.9.04954 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.9.04955 Boehringer Ingelheim Investigational Site

Bruchsal, Germany

Location

1237.9.04959 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

Location

1237.9.04960 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1237.9.04958 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.9.04951 Boehringer Ingelheim Investigational Site

Tübingen, Germany

Location

1237.9.04956 Boehringer Ingelheim Investigational Site

Wiesloch, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

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)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 22, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Last Updated: August 17, 2015
• Results First Posted: August 17, 2015

Record last verified: 2015-07

Locations

CA (5); DE (9); BE (5); US (5)