Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease

NCT01559116 | Completed Phase 3 Results

• 2 other identifiers: 1237.202011-004710-42
• Study Type: interventional
• Target: 219
• Locations: 7 countries
• Sites: 29

Brief Summary

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC, administered once daily by the RESPIMAT Inhaler after 6 weeks of treatment.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1 Second (FEV1) AUC0-24h Response [L] After 6 Weeks Treatment.

  Area under the Forced Expiratory Volume in 1 second (FEV1) after 6 weeks treatement-time curve from 0 to 24 h post-dose, using the trapezoidal rule, divided by the duration (24 h) to report in litres. Mean is actually the Adjusted mean. The adjusted mean and standard error (SE) are obtained from fitting a mixed effect model repeated measures (MMRM) including fixed effects of treatment and period; period baseline and patient baseline as covariates; patient as a random effect; compound symmetry covariance structure for within-patient variation and Kenward-Roger approximation of denominator degrees of freedom.

  day 1 and week 6

Secondary Outcomes (9)

• FEV1 AUC0-12h Response [L] After 6 Weeks Treatment.

  day 1 and week 6

• FEV1 AUC12-24h Response [L] After 6 Weeks Treatment.

  day 1 and week 6

• Trough FEV1 Response [L] After 6 Weeks Treatment.

  day 1 and week 6

• Peak(0-3h) FEV1 Response [L] After 6 Weeks Treatment.

  day 1 and week 6

• FVC AUC0-24h Response [L] After 6 Weeks Treatment.

  day 1 and week 6

Study Arms (6)

tiotropium+olodaterol FDC low dose

EXPERIMENTAL

tiotropium+olodaterol FDC low dose; 2 inhalations once daily (a.m. dosing)

Drug: tiotropium + olodaterol; Device: Respimat

tiotropium+olodaterol FDC high dose

EXPERIMENTAL

tiotropium+olodaterol FDC high dose; 2 inhalations once daily (a.m. dosing)

Drug: tiotropium + olodaterol; Device: Respimat

tiotropium low dose

ACTIVE COMPARATOR

tiotropium low dose; 2 inhalations once daily (a.m. dosing)

Drug: tiotropium; Device: Respimat

tiotropium high dose

ACTIVE COMPARATOR

tiotropium high dose; 2 inhalations once daily (a.m. dosing)

Drug: tiotropium; Device: Respimat

olodaterol

ACTIVE COMPARATOR

one dose only; 2 inhalations once daily (a.m. dosing)

Drug: olodaterol; Device: Respimat

placebo

PLACEBO COMPARATOR

2 inhalations once daily (a.m. dosing)

Drug: Placebo; Device: Respimat

Interventions

tiotropium + olodaterol DRUG

low dose + one dose only

tiotropium+olodaterol FDC high dose

tiotropium DRUG

low dose

tiotropium low dose

olodaterol DRUG

one dose only

olodaterol

Placebo DRUG

placebo matching tiotropium+olodaterol FDC

placebo

Respimat DEVICE

Respimat inhaler

olodaterol; placebo; tiotropium high dose; tiotropium low dose; tiotropium+olodaterol FDC high dose; tiotropium+olodaterol FDC low dose

Eligibility Criteria

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

You may qualify if:

• Diagnosis of chronic obstructive pulmonary disease
• Relatively stable airway obstruction with a post-bronchodilator FEV1\< 80% of predicted normal and a post-bronchodilator FEV1/FVC \<70%
• Male or female patients, 40 years of age or older
• Smoking history of more than 10 pack years
• Ability to perform technically acceptable pulmonary function tests and maintain records
• Ability to inhale medication in a competent manner from the RESPIMAT Inhaler and from a metered dose inhaler (MDI)

You may not qualify if:

• significant disease other than COPD
• clinically relevant abnormal lab values
• history of asthma
• diagnosis of thyrotoxicosis
• diagnosis of paroxysmal tachycardia
• history of myocardial infarction
• unstable or life-threatening cardiac arrhythmia
• Hospitalization for heart failure within the past year
• known active tuberculosis
• malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• history of life-threatening pulmonary obstruction
• history of cystic fibrosis
• clinically evident bronchiectasis
• history of significant alcohol or drug abuse
• history of thoracotomy with pulmonary resection

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (29)

1237.20.1204 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1237.20.1203 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Location

1237.20.1201 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1237.20.1202 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1237.20.32203 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1237.20.32201 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1237.20.32204 Boehringer Ingelheim Investigational Site

Jambes, Belgium

Location

1237.20.02202 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Location

1237.20.02201 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Location

1237.20.45002 Boehringer Ingelheim Investigational Site

Hvidovre, Denmark

Location

1237.20.45003 Boehringer Ingelheim Investigational Site

Odense C, Denmark

Location

1237.20.45001 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

Location

1237.20.49205 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1237.20.49204 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1237.20.49203 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.20.49206 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1237.20.49201 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1237.20.49207 Boehringer Ingelheim Investigational Site

Mönchengladbach, Germany

Location

1237.20.49202 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

1237.20.36202 Boehringer Ingelheim Investigational Site

Gödöllö, Hungary

Location

1237.20.36204 Boehringer Ingelheim Investigational Site

Komárom, Hungary

Location

1237.20.36203 Boehringer Ingelheim Investigational Site

Pécs, Hungary

Location

1237.20.36201 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

Location

1237.20.36205 Boehringer Ingelheim Investigational Site

Százhalombatta, Hungary

Location

1237.20.31205 Boehringer Ingelheim Investigational Site

Almelo, Netherlands

Location

1237.20.31202 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1237.20.31201 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1237.20.31204 Boehringer Ingelheim Investigational Site

Hengelo, Netherlands

Location

1237.20.31203 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

Location

Related Publications (1)

• Beeh KM, Westerman J, Kirsten AM, Hebert J, Gronke L, Hamilton A, Tetzlaff K, Derom E. The 24-h lung-function profile of once-daily tiotropium and olodaterol fixed-dose combination in chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2015 Jun;32:53-9. doi: 10.1016/j.pupt.2015.04.002. Epub 2015 May 6.

  PMID: 25956072 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: March 19, 2012
• First Posted: March 21, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 16, 2015
• Results First Posted: July 16, 2015

Record last verified: 2015-06

Locations

US (4); CA (2); BE (3); DK (3); DE (7); HU (5); NL (5)