Overview

This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Treatments olodaterol, tiotropium
Phase phase 3
Sponsor Boehringer Ingelheim
Start date January 2015
End date March 2017
Trial size 7910 participants
Trial identifier NCT02296138, 1237.19, 2014-002275-28

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 COPD exacerbation in patients with severe to very severe COPD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment
Arm
(Experimental)
Once daily 2 puffs solution for inhalation Respimat
olodaterol
fixed dose combination
tiotropium
fixed dose combination
(Active Comparator)
Once daily 2 puffs solution for inhalation Respimat
tiotropium

Primary Outcomes

Measure
Primary endpoint: annualised rate of moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).
time frame: 52 weeks + 1 day

Secondary Outcomes

Measure
Key secondary endpoint: time to first moderate to severe COPD exacerbation during the treatment period (within 1 day after the last drug administration date).
time frame: 52 weeks + 1 day
Annualised rate of exacerbation leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
time frame: 52 weeks + 1 day
Time to first COPD exacerbations leading to hospitalisation during the treatment period (within 1 day after the last drug administration date).
time frame: 52 weeks + 1 day
Time to all-cause mortality (within 1 day after the last drug administration date).
time frame: 52 weeks+ 1 day

Eligibility Criteria

Male or female participants at least 40 years old.

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/FVC (Forced vital capacity) <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.

Additional Information

Official title A Randomised, Double-blind, Active-controlled Parallel Group Study to Evaluate the Effect of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared With Tiotropium on Chronic Obstructive Pulmonary Disease (COPD) Exacerbation in Patients With Severe to Very Severe COPD. [DYNAGITO]
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.