Health Condition 1: J455- Severe persistent asthma
Conditions
Interventions
Intervention1: FDC of Fluticasone Furoate, Umeclidinium and Vilanterol powder for inhalation (200mcg + 62.5mcg + 25mcg): Capsules are to be used through Octahaler for inhalation once daily. Capsules a
Sponsors
Sun Pharma Laboratories Limited
Sun Pharma Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Patient will be included if all the inclusion criteria listed below are met: 1. Patients of either gender with age between 18 to 65 years (both inclusive) and willing to provide written informed consent 2. Patients with a diagnosis of bronchial asthma as per GINA 2024 for a period of at least 1 year prior to Screening 3. Patients who have symptomatic uncontrolled bronchial asthma after using medium or high dose of inhaled corticosteroids (ICS) and long-acting beta-2 agonists (LABA) combinations for asthma for at least 3 months and at stable dose for at least 1 month prior to Screening 4. In pre-bronchodilator spirometry, patients with trough Forced expiratory volume in one second (FEV1) of 40% to 80% of the predicted normal value for the patient 5. In post-bronchodilator spirometry, patients who demonstrate an increase in FEV1 OR Forced vital capacity (FVC) of greater than or equal to 12% AND greater than or equal to 200 mL from pre-bronchodilator reading 6. Patients with documented history of at least one asthma exacerbation which required medical care from a physician or visit to emergency (or local equivalent structure) or hospitalization within 12 months prior to Screening (but no exacerbation within 6 weeks prior to Screening) or documented temporary change in asthma therapy for exacerbation 7. Women of childbearing potential must have a negative urine pregnancy test prior to 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. Post-menopausal 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] 8. Male patients must have had a successful vasectomy (confirmed azoospermia) or they 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: Patients will be excluded if any of the exclusion criteria listed below is met: 1. Patients with known hypersensitivity or any other contraindication to any of the Investigational products or any of its components 2. Patients with history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis and clinically significant bronchiectasis 3. Patients with history of active pulmonary or extra-pulmonary tuberculosis within 1 year prior to Screening OR a positive report on QuantiFERON TB Gold test at Screening 4. Patients with history of intubation for a severe asthma attack/exacerbation 5. Patients with history of acute respiratory tract infection within 4 weeks prior to Screening OR during the Run-in period 6. Patient with oropharyngeal candidiasis within 4 weeks prior to Screening OR during the Run-in period 7. Patients with history of Immunotherapy (desensitization) for allergies within 3 months prior to Screening 8. Patients with history of irregular sleep-wake cycle 9. Patients with history of any chronic conditions affecting the upper respiratory tract (like but not limited to: chronic sinusitis, nasal polyp, etc.) 10. Patients treated with parenteral corticosteroids (except systemic corticosteroids for treatment of asthma exacerbation) within 4 weeks prior to Run-in visit OR intramuscular depot corticosteroids within 3 months prior to Run-in visit 11. Patients with history of live/ live attenuated vaccination within 4 weeks prior to Screening or planning for vaccination during the course of the study or within 4 weeks after study completion 12. Patients treated with asthma medications but not meeting the required stable dosing period 13. Patients with history of any clinically significant medical and/or psychological condition that, in the opinion of the Investigator would jeopardize the safety of the patient or affect the validity of the study results [for example but not limited to: renal impairment (if serum creatinine greater than or equal to 2 x ULN), cardiovascular disorders (like: ischemic heart disease, NYHA Class III/IV left ventricular failure, arrhythmia, atrial fibrillation, myocardial infarction, angina, congestive heart failure, long QT syndrome, etc.), cerebrovascular disease, ophthalmologic disease, psychiatric disorder, neurodegenerative disease, epilepsy or seizure disorder or any neurological disorder, any autoimmune disorders, uncontrolled thyroid disorder, hypokalemia (serum potassium lesser than 3.5 mEq/L), hepatic impairment (if ALT greater than or equal to 3 x ULN OR AST greater than or equal to 3 x ULN OR ALP greater than or equal to 3 x ULN OR total bilirubin greater than or equal to 1.5 x ULN)] 14. Patients with Type I diabetes mellitus or uncontrolled Type II diabetes mellitus (HbA1c greater than or equal to 9%) 15. Patients with prolonged QTcF [greater than 450 ms in males and greater than 460 ms in females] in 12-lead ECG or any other clinically significant abnormal ECG findings at Screening 16. Patients with history of severe narcolepsy or insomnia 17. Pregnant and/or lactating female 18. Patient with history of HIV and/or HBV and/or HCV infection 19. Patients who have smoked or inhaled tobacco products (including nicotine inhalers like e-cigarettes) within 6 months prior to Screening <br/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FEV1Timepoint: Baseline, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in trough FVCTimepoint: Baseline, Weeks 4, 8 and 12;Change from baseline in trough FEV1/FVCTimepoint: Baseline, Weeks 4, 8 and 12;Change from baseline in post-dose FEV1Timepoint: Baseline, Week 12;Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) total scoreTimepoint: Baseline, Week 12;Proportion of participants with treatment emergent (TEAEs) and serious adverse events (SAEs)Timepoint: Throughout the study period | — |
Countries
India
Contacts
Public ContactDigambar Tornale
Sun Pharma Laboratories Limited
Outcome results
None listed