Health Condition 1: J984- Other disorders of lung
Conditions
Interventions
Intervention1: Revefenacin: For oral inhalation use
only
One 175 mcg vial (3
mL) once daily.
For use with a standard
jet nebulizer with a
mouthpiece connected
to an air compressor
Control Intervention
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Laboratories Ltd SPLL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients of either gender with age between 40 to 65 years (both inclusive) at screening and willing to provide written informed consent 2.Patients with a diagnosis of COPD as per Global initiative for Chronic Obstructive Lung Disease (GOLD) 2025 for a period of at least 1 month prior to Screening 3.Patients who are on combination therapy of long-acting muscarinic antagonist (LAMA) + long-acting beta-2 agonist (LABA) + Inhaled corticosteroids (ICS) for at least one month prior to screening visit. 4.Patients with pre-bronchodilator and post-bronchodilator (post-salbutamol) Forced expiratory volume in one second (FEV1)/ Forced Vital Capacity (FVC) less than 0.7 at screening and post-salbutamol FEV1 greater than or equal to 30 percent to less than 80 percent of predicted at screening. Patient should have FEV1 greater than or equal to 30 percent to less than 80% at baseline i.e.,randomization visit. 5.Patients with Modified Medical Research Council (mMRC) dyspnoea grade greater than or equal to 2 at screening and randomization visit. 6.Women of childbearing potential must have a negative urine pregnancy test at Screening and Randomization and agree to use highly effective methods of contraception to prevent pregnancy from study entry till end of study (such contraception may include hormonal birth control e.g. combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral,injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence OR non-hormonal contraception [e.g. condoms with spermicide]) [Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Postmenopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age] 7.Male patients must have had a successful vasectomy (confirmed azoospermia) or should practice highly effective contraception throughout the study period and their female partners must meet the criteria above (i.e., not of childbearing potential or practicing highly effective contraception throughout the study period) [No sperm donation is allowed during the study period]
Exclusion criteria
Exclusion criteria: 1.Patients with known hypersensitivity or any other contraindication to any of the revefenacin or tiotropium products or any of its components, any reactions to inhaled or nebulized anticholinergics or short-acting beta agonists 2.Patients with history of chronic lung diseases other than COPD, including (but not limited to) asthma, sarcoidosis, interstitial lung disease, cystic fibrosis, Clinically significant bronchiectasis, restrictive lung disorders, lung tumors (benign or malignant), pulmonary tuberculosis, occupational disease such as silicosis or asbestosis affecting lungs, any other inflammatory lung disorder, alpha-1-antitrypsin deficiency, scoliosis, intercostal muscle disease, myasthenia gravis, phrenic nerve palsy 3.Patients receiving monotherapy, who are treatment-na ve, and those on Short-Acting Muscarinic Antagonist (SAMA) + Short-Acting Beta-Agonist (SABA) (with or without steroids) or on Long-Acting Muscarinic Antagonist (LAMA) + Long-Acting Beta-Agonist (LABA) will be excluded 4.Hospitalization for COPD or pneumonia within 8 weeks prior to Screening 5. Use of antimicrobial therapy for respiratory tract infection within 6 weeks of screening 6.Significantly increased risk of cardiovascular events, as indicated by a history of myocardial infarction or unstable angina within the last 6 months, unstable or life-threatening cardiac arrhythmia requiring intervention in the last 3 months, and New York Heart Association (NYHA) Class III or IV heart failure 7.Subject has an abnormal and clinically significant 12-lead ECG findings at screening atrial fibrillation (AF) with rapid ventricular rate greater than 120 beats per minute sustained or non-sustained ventricular tachycardia (VT) second or third degree heart block (unless pacemaker had been inserted) QT interval corrected for heart rate (QTcF) greater than or equal to500 milliseconds (msec) 8.Use of systemic corticosteroids within 6 weeks prior to screening 9.Patients with history of active pulmonary or extra-pulmonary tuberculosis within 1 year prior to Screening OR a positive report on QuantiFERON tuberculosis (TB) Gold test at Screening 10.History of lung volume reduction surgery or lobectomy within 12 months prior to screening 11.Patients requiring long term oxygen therapy (greater than 12 hours a day) 12.History of known or suspected alcohol or drug abuse within 2 years prior to screening 13.Patients having COPD exacerbation and taking prohibited medications during the screening and/or run-in period 14.Patients taking prohibited medication before screening within the duration specified in prohibited medication list 15.Patients with history of intubation for a severe COPD attack/exacerbation 16.Patients with history of any clinically significant medical and/or psychological condition that, in theopinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results. 17.Patient with history of thyrotoxicosis 18.Patients with positive test of human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg) or hepatitis B surface antigen (HCV) 19.Pregnant and/or lactating female 20.Patients with any clinically significant laboratory investigation result that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Baseline, Weeks 4 and 8;Change from baseline in trough FVCTimepoint: Baseline, Weeks 4, 8 and 12;Change from baseline in 1 hr post-dose FEV1Timepoint: Baseline, Week 12;Proportion of rescue-free daytime periodsTimepoint: Weeks 4, 8 and 12;Proportion of rescue-free night-time periodsTimepoint: Weeks 4, 8 and 12;Change from baseline in short-form 36-item questionnaire (SF-36)Timepoint: Baseline, Weeks 4, 8 and 12 ;Incidence of treatment emergent (TEAEs) and serious adverse events (SAEs)Timepoint: Throughout the study period;Incidence of COPD exacerbations COPD exacerbation is defined as an acute worsening of symptoms of COPD (dyspnea and/or cough and sputum that worsen over less than 14 days) requiring the use of any treatment beyond study medication or rescue medicationTimepoint: Weeks 4, 8 and 12 | — |
Countries
India
Contacts
Public ContactDigambar Tornale
Sun Pharma Laboratories Limited
Outcome results
None listed