Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD Patients.

NCT01533935 | Completed Phase 3 Results

• 2 other identifiers: 1237.142011-004660-30
• Study Type: interventional
• Target: 291
• Locations: 8 countries
• Sites: 33

Brief Summary

The primary objective of this trial is to investigate the effect of 6 weeks treatment with tiotropium + olodaterol fixed dose combination inhalation solution on lung hyperinflation and exercise tolerance in patients with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Inspiratory Capacity at Rest Before Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity

  Inspiratory capacity (IC) at rest before constant work rate cycle ergometry to symptom limitation at 75% maximal work capacity (Wcap). Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted means from the MMRM (Mixed Effects Model Repeated Measures) model.

  6 weeks

• Endurance Time During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap

  Endurance time during constant work rate cycle ergometry (CWRCE) to symptom limitation at 75% Wcap Wcap was defined as the maximum work rate achieved for at least 30 seconds during the incremental cycle ergometry performed at Visit 1. The presented means are adjusted mean from the MMRM model.

  6 weeks

Secondary Outcomes (2)

• Slope of the Intensity of Breathing Discomfort (Borg Scale) During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Wcap

  6 weeks

• FEV1 (1 Hour Post-dose)

  6 weeks

Study Arms (5)

Olodaterol 5 mcg QD

ACTIVE COMPARATOR

patient will receive olodaterol 5 mcg once daily

Drug: Olodaterol; Device: Respimat

Placebo QD

PLACEBO COMPARATOR

placebo comparator for tiotropium + olodaterol

Drug: Placebo; Device: Respimat

Tiotropium 5 mcg QD

ACTIVE COMPARATOR

patient will receive tiotropium 5 mcg once daily

Drug: Tiotropium; Device: Respimat

Tiotropium + olodaterol low dose QD

EXPERIMENTAL

patient will receive tiotropium 2.5 mcg + olodaterol 5 mcg in fixed dose combination once daily

Drug: Tiotropium + Olodaterol; Device: Respimat

Tiotropium + olodaterol high dose

EXPERIMENTAL

patient will receive tiotropium 5 mcg + olodaterol 5 mcg in fixed dose combination once daily

Drug: tiotropium + Olodaterol; Device: Respimat

Interventions

Placebo DRUG

placebo matching tiotropium + olodaterol

Placebo QD

tiotropium + Olodaterol DRUG

Tiotropium 2.5 mcg + olodaterol 5 mcg once daily

Tiotropium + olodaterol low dose QD

Tiotropium DRUG

tiotropium

Tiotropium 5 mcg QD

Olodaterol DRUG

Olodaterol 5 mcg once daily

Olodaterol 5 mcg QD

Respimat DEVICE

Respimat inhaler

Olodaterol 5 mcg QD; Placebo QD; Tiotropium + olodaterol high dose; Tiotropium + olodaterol low dose QD; Tiotropium 5 mcg QD

Eligibility Criteria

• Age: 40 Years - 75 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 \<80% of predicted normal and a post-bronchodilator FEV1/FVC \<70% at Visit 1.
• Male or female patients, between 40 and 75 years of age (inclusive) on day of signing informed consent.
• 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; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
• Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN will be excluded regardless of clinical condition
• Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
• 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 (\>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
• A history of myocardial infarction within 1 year of screening visit (Visit 1)
• Unstable or life-threatening cardiac arrhythmia
• Hospitalized for heart failure within the past year
• Known active tuberculosis
• A malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
• A history of life-threatening pulmonary obstruction
• A history of cystic fibrosis
• Clinically evident bronchiectasis
• A history of significant alcohol or drug abuse

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (33)

1237.14.01404 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1237.14.01414 Boehringer Ingelheim Investigational Site

Austell, Georgia, United States

Location

1237.14.01417 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1237.14.01418 Boehringer Ingelheim Investigational Site

Rochester, Minnesota, United States

Location

1237.14.01408 Boehringer Ingelheim Investigational Site

Saint Charles, Missouri, United States

Location

1237.14.01409 Boehringer Ingelheim Investigational Site

Charlotte, North Carolina, United States

Location

1237.14.01407 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1237.14.01403 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1237.14.01401 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Location

1237.14.01412 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Location

1237.14.01410 Boehringer Ingelheim Investigational Site

Seattle, Washington, United States

Location

1237.14.54402 Boehringer Ingelheim Investigational Site

Buenos Aires, Argentina

Location

1237.14.54401 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Location

1237.14.43402 Boehringer Ingelheim Investigational Site

Grieskirchen, Austria

Location

1237.14.43401 Boehringer Ingelheim Investigational Site

Neumarkt am Wallersee, Austria

Location

1237.14.11404 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1237.14.11403 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1237.14.11402 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1237.14.11401 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Location

1237.14.49406 Boehringer Ingelheim Investigational Site

Bamberg, Germany

Location

1237.14.49404 Boehringer Ingelheim Investigational Site

Bochum, Germany

Location

1237.14.49401 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1237.14.49405 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.14.49403 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1237.14.49402 Boehringer Ingelheim Investigational Site

Kiel, Germany

Location

1237.14.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1237.14.31005 Boehringer Ingelheim Investigational Site

Hoofddorp, Netherlands

Location

1237.14.31004 Boehringer Ingelheim Investigational Site

Hoorn, Netherlands

Location

1237.14.31006 Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

1237.14.31007 Boehringer Ingelheim Investigational Site

Leiden, Netherlands

Location

1237.14.70401 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1237.14.70402 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1237.14.46001 Boehringer Ingelheim Investigational Site

Lund, Sweden

Location

Related Publications (1)

• O'Donnell DE, Casaburi R, Frith P, Kirsten A, De Sousa D, Hamilton A, Xue W, Maltais F. Effects of combined tiotropium/olodaterol on inspiratory capacity and exercise endurance in COPD. Eur Respir J. 2017 Apr 19;49(4):1601348. doi: 10.1183/13993003.01348-2016. Print 2017 Apr.

  PMID: 28424359 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol; Tiotropium Bromide; olodaterol

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: February 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 15, 2015
• Results First Posted: September 15, 2015

Record last verified: 2015-08

Locations

DE (6); RU (2); US (11); CA (4); AU (2); AR (2); SE (1); NL (5)