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

NCT01533922 | Completed Phase 3 Results

• 2 other identifiers: 1237.132011-004659-37
• Study Type: interventional
• Target: 295
• Locations: 9 countries
• Sites: 42

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% Wcap

  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% 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 mean from the MMRM model.

  6 weeks

Secondary Outcomes (2)

• Slope of the Intensity of Breathing Discomfort During Constant Work Rate Cycle Ergometry to Symptom Limitation at 75% Work Capacity

  6 weeks

• Forced Expiratory Volume in 1 Second (One Hour Post-dose)

  6 weeks

Study Arms (5)

Tiotropium + olodaterol High dose QD

EXPERIMENTAL

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

Drug: tiotropium + olodaterol; Device: Respimat

Tiotropium + olodaterol Low dose QD

EXPERIMENTAL

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

Drug: Tiotropium + Olodaterol; Device: Respimat

Tiotropium 5 mcg QD

ACTIVE COMPARATOR

patient will receive tiotropium 5 mcg once daily

Drug: Tiotropium; Device: Respimat

Olodaterol 5 mcg QD

ACTIVE COMPARATOR

patient will receive olodaterol 5 mcg once daily

Drug: Olodaterol; Device: Respimat

Placebo QD

PLACEBO COMPARATOR

Drug: Placebo; Device: Respimat

Interventions

Placebo DRUG

placebo matching tiotropium + olodaterol FDC

Placebo QD

Tiotropium DRUG

Tiotropium 5 mcg once daily

Tiotropium 5 mcg QD

Olodaterol DRUG

Olodaterol 5 mcg once daily

Olodaterol 5 mcg QD

Tiotropium + Olodaterol DRUG

tiotropium + olodaterol 5 mcg once daily

Tiotropium + olodaterol High dose QD

Respimat DEVICE

Respimat inhaler

Olodaterol 5 mcg QD; Placebo QD; Tiotropium + olodaterol High dose QD; 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 (44)

1237.13.01302 Boehringer Ingelheim Investigational Site

Torrance, California, United States

Location

1237.13.01308 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

1237.13.01304 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Location

1237.13.01307 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1237.13.01305 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1237.13.01301 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1237.13.01303 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1237.13.01306 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1237.13.54301 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1237.13.54302 Boehringer Ingelheim Investigational Site

Mar del Plata, Argentina

Location

1237.13.61306 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Location

1237.13.61301 Boehringer Ingelheim Investigational Site

Daw Park, South Australia, Australia

Location

1237.13.61305 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Location

1237.13.61304 Boehringer Ingelheim Investigational Site

Footscray, Victoria, Australia

Location

1237.13.61302 Boehringer Ingelheim Investigational Site

Prahran, Victoria, Australia

Location

1237.13.43303 Boehringer Ingelheim Investigational Site

Linz, Austria

Location

1237.13.43301 Boehringer Ingelheim Investigational Site

Thalheim bei Wels, Austria

Location

1237.13.32302 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1237.13.32303 Boehringer Ingelheim Investigational Site

Edegem, Belgium

Location

1237.13.32305 Boehringer Ingelheim Investigational Site

Jambes, Belgium

Location

1237.13.32304 Boehringer Ingelheim Investigational Site

Lanaken, Belgium

Location

1237.13.32301 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

1237.13.11302 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1237.13.11303 Boehringer Ingelheim Investigational Site

Kingston, Ontario, Canada

Location

1237.13.11304 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1237.13.56301 Boehringer Ingelheim Investigational Site

Chile, Chile

Location

1237.13.56302 Boehringer Ingelheim Investigational Site

Santiago, Chile

Location

1237.13.49302 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.13.49307 Boehringer Ingelheim Investigational Site

Dortmund, Germany

Location

1237.13.49304 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

1237.13.49301 Boehringer Ingelheim Investigational Site

Halle, Germany

Location

1237.13.49303 Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

1237.13.49305 Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

1237.13.39302 Boehringer Ingelheim Investigational Site

Genova, Italy

Location

1237.13.39304 Boehringer Ingelheim Investigational Site

Parma, Italy

Location

1237.13.39303 Boehringer Ingelheim Investigational Site

Pavia, Italy

Location

1237.13.39305 Boehringer Ingelheim Investigational Site

Pavullo Nel Frignano (mo), Italy

Location

1237.13.39301 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1237.13.39312 Boehringer Ingelheim Investigational Site

Pisa, Italy

Location

1237.13.39310 Boehringer Ingelheim Investigational Site

Roma, Italy

Location

1237.13.39308 Boehringer Ingelheim Investigational Site

Sesto S. Giovanni (mi), Italy

Location

1237.13.39306 Boehringer Ingelheim Investigational Site

Trieste, Italy

Location

1237.13.64302 Boehringer Ingelheim Investigational Site

Christchurch, New Zealand

Location

1237.13.64301 Boehringer Ingelheim Investigational Site

Greenlane East Auckland NZ, New Zealand

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 Bromide; olodaterol; tiotropium-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: March 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

IT (9); AU (5); NZ (2); CL (2); BE (5); US (8); AR (2); CA (3); DE (6)