Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)

NCT01040403 | Completed Phase 2 Results

• 2 other identifiers: 1237.182009-014880-38
• Study Type: interventional
• Target: 233
• Locations: 4 countries
• Sites: 33

Brief Summary

The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week treatment in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 Response

  Adjusted means of the trough forced expiratory volume in one second (FEV1) response (L) after four weeks treatment. The trough was defined as the mean of the 1 h pre-dose and 10 min pre-dose measurements on day 29. Baseline was defined as the mean of the 2 pre-treatment FEV1 values measured on day 1 (-1 hour and -10 minutes) prior to administration of the first dose of study drug.

  Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29

Secondary Outcomes (21)

• Trough Forced Vital Capacity (FVC) Response

  Baseline and 1 hour pre-dose and 10 minutes pre-dose on day 29

• FEV1 AUC 0-3h and FEV1 AUC 0-6h Response

  Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post dose for AUC0-3h and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h 4 h, 5 h, 6 h postdose for AUC0-6h on day 29

• FEV1 AUC 0-3h Response After the First Dose

  Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

• FEV1 Peak 0-3h Response

  Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 29

• FEV1 Peak 0-3h Response After the First Dose

  Baseline and 1 h, 10 min pre-dose and 5 min, 30 min, 1 h, 2 h, 3 h post-dose on day 1

Study Arms (8)

olodaterol (BI 1744) low and placebo

EXPERIMENTAL

low dose inhaled olodaterol orally once daily from the Respimat inhaler

Drug: olodaterol (BI 1744) low; Drug: Placebo; Device: Respimat

olodaterol (BI 1744) low and low tio

EXPERIMENTAL

low dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: olodaterol (BI 1744) low; Drug: low tiotropium bromide; Device: Respimat

olodaterol (BI 1744) low and medium tio

EXPERIMENTAL

low dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: olodaterol (BI 1744) low; Drug: medium tiotropium bromide; Device: Respimat

olodaterol (BI 1744) low and high tio

EXPERIMENTAL

low dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: olodaterol (BI 1744) low; Drug: high tiotropium bromide; Device: Respimat

olodaterol (BI 1744) high and placebo

EXPERIMENTAL

high dose inhaled olodaterol orally once daily from the Respimat inhaler

Drug: olodaterol (BI 1744) high; Drug: Placebo; Device: Respimat

Olodaterol (BI 1744) high and low tio

EXPERIMENTAL

high dose inhaled olodaterol and low dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: low tiotropium bromide; Drug: olodaterol (BI 1744) high; Device: Respimat

Olodaterol (BI 1744) high and medium tio

EXPERIMENTAL

high dose inhaled olodaterol and medium dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: olodaterol (BI 1744) high; Drug: medium tiotropium bromide; Device: Respimat

Olodaterol (BI 1744) high and high tio

EXPERIMENTAL

high dose inhaled olodaterol and high dose inhaled tiotropium, both from the Respimat inhaler and once daily

Drug: olodaterol (BI 1744) high; Drug: high tiotropium bromide; Device: Respimat

Interventions

olodaterol (BI 1744) low DRUG

olodaterol (BI 1744) low

olodaterol (BI 1744) low and high tio; olodaterol (BI 1744) low and low tio; olodaterol (BI 1744) low and medium tio; olodaterol (BI 1744) low and placebo

low tiotropium bromide DRUG

low tiotropium bromide

Olodaterol (BI 1744) high and low tio; olodaterol (BI 1744) low and low tio

olodaterol (BI 1744) high DRUG

olodaterol (BI 1744) high

Olodaterol (BI 1744) high and high tio; Olodaterol (BI 1744) high and low tio; Olodaterol (BI 1744) high and medium tio; olodaterol (BI 1744) high and placebo

medium tiotropium bromide DRUG

medium tiotropium bromide

Olodaterol (BI 1744) high and medium tio; olodaterol (BI 1744) low and medium tio

high tiotropium bromide DRUG

high tiotropium bromide

Olodaterol (BI 1744) high and high tio; olodaterol (BI 1744) low and high tio

Placebo DRUG

Placebo

olodaterol (BI 1744) high and placebo; olodaterol (BI 1744) low and placebo

Respimat DEVICE

Respimat inhaler

Olodaterol (BI 1744) high and high tio; Olodaterol (BI 1744) high and low tio; Olodaterol (BI 1744) high and medium tio; olodaterol (BI 1744) high and placebo; olodaterol (BI 1744) low and high tio; olodaterol (BI 1744) low and low tio; olodaterol (BI 1744) low and medium tio; olodaterol (BI 1744) low and placebo

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
• All patients must have a diagnosis of chronic obstructive pulmonary disease (COPD) must meet the following spirometric criteria:
• a post-bronchodilator forced expiratory flow in 1 second (FEV1) =\<30% of predicted normal and \<80% of predicted normal and a post bronchodilator FEV1 / forced vital capacity (FVC) \<70% at Visit 1 4. Male or female patients, 40 years of age or older. 5. Patients must be current or ex-smokers with a smoking history of more than 10 pack years

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 (due to the known class side effect profile of ß2-agonists) a diagnosis of paroxysmal tachycardia - Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit a diagnosis of clinically relevant cardiac arrhythmia a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• Patients who have undergone thoracotomy with pulmonary resection
• Patients being treated with the following concomitant medications:
• medications that prolong the QT/QTc interval oral Beta-adrenergics oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
• \- Pregnant or nursing women

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (33)

1237.18.02004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1237.18.02005 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

Location

1237.18.02001 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1237.18.02008 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1237.18.02002 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1237.18.02003 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Location

1237.18.02009 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1237.18.02007 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Location

1237.18.02011 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1237.18.49009 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

Location

1237.18.49012 Boehringer Ingelheim Investigational Site

Bamberg, Germany

Location

1237.18.49005 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.18.49004 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1237.18.49011 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.18.49010 Boehringer Ingelheim Investigational Site

Koblenz, Germany

Location

1237.18.49007 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1237.18.49001 Boehringer Ingelheim Investigational Site

Potsdam, Germany

Location

1237.18.49006 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, Germany

Location

1237.18.49002 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1237.18.49003 Boehringer Ingelheim Investigational Site

Weinheim, Germany

Location

1237.18.49008 Boehringer Ingelheim Investigational Site

Wiesloch, Germany

Location

1237.18.31004 Boehringer Ingelheim Investigational Site

Almelo, Netherlands

Location

1237.18.31006 Boehringer Ingelheim Investigational Site

Amsterdam, Netherlands

Location

1237.18.31008 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1237.18.31001 Boehringer Ingelheim Investigational Site

Groningen, Netherlands

Location

1237.18.31007 Boehringer Ingelheim Investigational Site

Hengelo, Netherlands

Location

1237.18.31005 Boehringer Ingelheim Investigational Site

Hoorn, Netherlands

Location

1237.18.31002 Boehringer Ingelheim Investigational Site

Veldhoven, Netherlands

Location

1237.18.31003 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

Location

1237.18.46003 Boehringer Ingelheim Investigational Site

Boden, Sweden

Location

1237.18.46002 Boehringer Ingelheim Investigational Site

Gothenburg, Sweden

Location

1237.18.46001 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

1237.18.46004 Boehringer Ingelheim Investigational Site

Stockholm, Sweden

Location

Related Publications (1)

• Aalbers R, Maleki-Yazdi MR, Hamilton A, Waitere-Wijker S, Zhao Y, Amatto VC, Schmidt O, Bjermer L. Randomized, Double-Blind, Dose-Finding Study for Tiotropium when Added to Olodaterol, Administered via the Respimat(R) Inhaler in Patients with Chronic Obstructive Pulmonary Disease. Adv Ther. 2015 Sep;32(9):809-22. doi: 10.1007/s12325-015-0239-8. Epub 2015 Sep 24.

  PMID: 26404912 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 28, 2009
• First Posted: December 29, 2009
• Study Start: January 1, 2010
• Primary Completion: February 1, 2011
• Last Updated: July 15, 2015
• Results First Posted: July 15, 2015

Record last verified: 2015-06

Locations

SE (4); NL (8); CA (9); DE (12)