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

Completed · Phase 3 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT01559116

Run by

Boehringer Ingelheim

People needed

219

Starts

2012-03-01

Expected to finish

2013-08-01

Last updated by the study team

2015-07-16

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

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
• oral or patch ß-adrenergics
• oral corticosteroid medication at unstable doses
• regular use daytime oxygen therapy for more than one hour per day
• Pulmonary rehabilitation program in the six weeks prior to the screening visit
• Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
• Known hypersensitivity to ß-adrenergic drugs, BAC, EDTA
• Pregnant or nursing women
• Women of childbearing potential not using a highly effective method of birth control
• Patients who have previously been randomised in this study or are currently participating in another study
• Patients who are unable to comply with pulmonary medication restrictions prior to randomisation

Where it is running

• 1237.20.1204 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
• 1237.20.1203 Boehringer Ingelheim Investigational Site — Easley, South Carolina, United States
• 1237.20.1201 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
• 1237.20.1202 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1237.20.32203 Boehringer Ingelheim Investigational Site — Genk, Belgium
• 1237.20.32201 Boehringer Ingelheim Investigational Site — Ghent, Belgium
• 1237.20.32204 Boehringer Ingelheim Investigational Site — Jambes, Belgium
• 1237.20.02202 Boehringer Ingelheim Investigational Site — Québec, Quebec, Canada
• 1237.20.02201 Boehringer Ingelheim Investigational Site — Sherbrooke, Quebec, Canada
• 1237.20.45002 Boehringer Ingelheim Investigational Site — Hvidovre, Denmark
• 1237.20.45003 Boehringer Ingelheim Investigational Site — Odense C, Denmark
• 1237.20.45001 Boehringer Ingelheim Investigational Site — Silkeborg, Denmark
• 1237.20.49205 Boehringer Ingelheim Investigational Site — Berlin, Germany
• 1237.20.49204 Boehringer Ingelheim Investigational Site — Großhansdorf, Germany
• 1237.20.49203 Boehringer Ingelheim Investigational Site — Hamburg, Germany
• 1237.20.49206 Boehringer Ingelheim Investigational Site — Hamburg, Germany
• 1237.20.49201 Boehringer Ingelheim Investigational Site — Mannheim, Germany
• 1237.20.49207 Boehringer Ingelheim Investigational Site — Mönchengladbach, Germany
• 1237.20.49202 Boehringer Ingelheim Investigational Site — Wiesbaden, Germany
• 1237.20.36202 Boehringer Ingelheim Investigational Site — Gödöllö, Hungary
• 1237.20.36204 Boehringer Ingelheim Investigational Site — Komárom, Hungary
• 1237.20.36203 Boehringer Ingelheim Investigational Site — Pécs, Hungary
• 1237.20.36201 Boehringer Ingelheim Investigational Site — Szarvas, Hungary
• 1237.20.36205 Boehringer Ingelheim Investigational Site — Százhalombatta, Hungary
• 1237.20.31205 Boehringer Ingelheim Investigational Site — Almelo, Netherlands

Full record on ClinicalTrials.gov

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