Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02296138 ↗
Enrolled (actual)
7,903
Serious AEs
21.2%
Results posted
Jun 2018
Primary outcomePrimary: Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period. — 0.97; 0.90 Rate per patient-year — p=0.0498
◆ Published Evidence
Highly cited
198citations · ~25 / year
Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial.
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.
Linked Publications (4)
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Tiotropium and olodaterol in the prevention of chronic obstructive pulmonary disease exacerbations (DYNAGITO): a double-blind, randomised, parallel-group, active-controlled trial.
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Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials.
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Safety of tiotropium/olodaterol in chronic obstructive pulmonary disease: pooled analysis of three large, 52-week, randomized clinical trials.
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Tiotropium/Olodaterol Decreases Exacerbation Rates Compared with Tiotropium in a Range of Patients with COPD: Pooled Analysis of the TONADO<sup>®</sup>/DYNAGITO<sup>®</sup> Trials.
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 |
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) and the linked publication. 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. Informational only — not medical advice.