Phase 3
N=7,903
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.
Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT02296138 ↗Enrolled (actual)
7,903
Serious AEs
21.2%
Results posted
Jun 2018
Primary outcome: Primary: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. — 0.97; 0.90 Rate per patient-year — p=0.0498
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- olodaterol (Drug); tiotropium (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. |
0.97; 0.90 | 0.0498 sig |
| SECONDARY Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period. |
1777; 1746 | 0.1188 |
| SECONDARY Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period. |
0.20; 0.18 | 0.1265 |
| SECONDARY Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period. |
469; 450 | 0.2773 |
| SECONDARY Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period. |
32; 36 | 0.7357 |
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.
Eligibility Criteria
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) 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.
Data sourced from ClinicalTrials.gov (NCT02296138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.