Status:
COMPLETED
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.
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
January 13 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2017
Estimated Enrollment :
7903 Patients enrolled
Trial Details
Trial ID
NCT02296138
Start Date
January 13 2015
End Date
March 29 2017
Last Update
June 4 2018
Active Locations (818)
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1
1237.19.10039 Boehringer Ingelheim Investigational Site
Andalusia, Alabama, United States
2
1237.19.10009 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
3
1237.19.10077 Boehringer Ingelheim Investigational Site
Florence, Alabama, United States
4
1237.19.10115 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States