COMING SOON – A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

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COMING SOON – A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

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A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

clinicaltrials.gov

Eligibility

Inclusion Criteria
  1. Male or female subjects aged ≥40 years
  2. A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential and is willing to use highly effective birth control methods for the full duration of the study
  3. COPD diagnosis for at least 12 months in accordance with the definition by the GOLD 2020 Report
  4. Current or ex-smokers who quit smoking at least 6 months prior with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]
  5. A post-bronchodilator FEV1 <50% predicted normal and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months
  6. Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months
  7. Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior, without evidence of significant abnormalities (other than those related to the presence of COPD).
Exclusion Criteria
  1. Female subjects who are pregnant or lactating
  2. Subjects using the following medications:
    • Systemic/oral/parenteral corticosteroids in the prior 4 weeks
    • Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
    • Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
    • Oral xanthine derivatives (e.g. theophylline) in the prior 7 days
  3. A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior
  4. Current treatment with non-cardioselective β-blockers
  5. Requirement of long term (> 15 hours daily) oxygen therapy
  6. Known respiratory disorders other than COPD which may impact the efficacy of the study drug
  7. Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year)
  8. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that would prevent use of anticholinergic agents
  9. History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug
  10. Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months
  11. An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings:
    • Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
    • Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
    • Evidence of Mobitz Type II second degree or third-degree atrioventricular block
    • Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.
  12. Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas
  13. History of alcohol abuse and/or substance/drug abuse (including marijuana inhaled and oral) within 12 months
  14. Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) or have been previously randomized in this trial, or are currently participating in another clinical trial
  15. Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
  16. Major surgery in the 3 months prior or have a planned surgery during the trial
  17. Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies.
  18. Veins unsuitable for repeat venipuncture
  19. Blood donation or blood loss (≥450mL) in the 4 weeks
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