Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease.

Completed · Phase 3

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

The overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the Respimat® inhaler) on moderate to severe COPD exacerbation in patients with severe to very severe COPD.

Key facts

Study ID

NCT02296138

Run by

Boehringer Ingelheim

People needed

7903

Starts

2015-01-13

Expected to finish

2017-03-29

Last updated by the study team

2018-06-04

Who can join

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

You may qualify if…

• Male or female patients, 40 years of age or older.
• Diagnosis of COPD with a documented post-bronchodilator Forced expiratory volume in one second (FEV1)< 60% of predicted normal and a post-bronchodilator FEV1/ forced vital capacity (FVC) <70% at Visit 1
• Documented history of at least one moderate to severe COPD exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization.
• Symptomatically stable as defined by: no evidence of COPD exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual COPD medication 4 weeks prior to visit 1.
• Current or ex-smokers with a smoking history of more than 10 pack years.

You may not qualify if…

• Significant disease other than COPD.
• Clinically relevant abnormal baseline haematology, blood chemistry or creatinine > x2 ULN will be excluded regardless of clinical condition. ( A repeat laboratory evaluation can be conducted if deemed necessary by the investigator.)
• Current documented diagnosis of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma
• A diagnosis of thyrotoxicosis
• A history of myocardial infarction within 6 months of screening visit.
• Life-threatening cardiac arrhythmia.
• Known active tuberculosis.
• Any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed).
• A history of cystic fibrosis.
• Clinically relevant bronchiectasis.
• Patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening
• A history of significant alcohol or drug abuse in the opinion of the investigator.
• Patients who have undergone thoracotomy with pulmonary resection
• Patients being treated with oral or patch ß-adrenergics.
• Patients being treated with oral corticosteroid medication at unstable doses
• Patients being treated with antibiotics for any reasons within 4 weeks of screening visit
• Patients being treated with PDE4 inhibitors within 3 months of screening visit
• Patients who have taken an investigational drug within one month or six half-lives
• Pregnant or nursing women.
• Women of childbearing potential not using a highly effective method of birth control.

Where it is running

• 1237.19.10009 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1237.19.10077 Boehringer Ingelheim Investigational Site — Florence, Alabama, United States
• 1237.19.10115 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States
• 1237.19.10069 Boehringer Ingelheim Investigational Site — Flagstaff, Arizona, United States
• 1237.19.10085 Boehringer Ingelheim Investigational Site — Peoria, Arizona, United States
• 1237.19.10110 Boehringer Ingelheim Investigational Site — Lincoln, California, United States
• 1237.19.10118 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1237.19.10074 Boehringer Ingelheim Investigational Site — Poway, California, United States
• 1237.19.10157 Boehringer Ingelheim Investigational Site — Lafayette, Colorado, United States
• 1237.19.10142 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1237.19.10133 Boehringer Ingelheim Investigational Site — Norwalk, Connecticut, United States
• 1237.19.10093 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1237.19.10029 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.19.10106 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
• 1237.19.10020 Boehringer Ingelheim Investigational Site — Orlando, Florida, United States
• 1237.19.10000 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 1237.19.10135 Boehringer Ingelheim Investigational Site — St. Petersburg, Florida, United States
• 1237.19.10145 Boehringer Ingelheim Investigational Site — Tamarac, Florida, United States
• 1237.19.10066 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
• 1237.19.10032 Boehringer Ingelheim Investigational Site — Winter Park, Florida, United States
• 1237.19.10080 Boehringer Ingelheim Investigational Site — Duluth, Georgia, United States
• 1237.19.10011 Boehringer Ingelheim Investigational Site — Gainesville, Georgia, United States
• 1237.19.10112 Boehringer Ingelheim Investigational Site — Lawrenceville, Georgia, United States
• 1237.19.10037 Boehringer Ingelheim Investigational Site — Eagle, Idaho, United States
• 1237.19.10039 Boehringer Ingelheim Investigational Site — Andalusia, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.