Health Condition 1: J45- Asthma
Conditions
Interventions
Intervention1: Beclometasone Dipropionate, Formoterol Fumarate Dihydrate, Glycopyrronium 172-5-9 mcg pressurised: Dose strength - Each delivered dose [the dose leaving the mouthpiece] contains 172 mic
Sponsors
Lupin Research Inc.
Cliantha Research Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Male or non-pregnant, non-lactating female aged between 18 to 65 years [both inclusive] at screening visit. 2. Participants who have physician-diagnosed asthma for at least 6 months prior to screening. 3. Pre bronchodilator Forced Expiratory Volume in 1 Second [FEV1] within 40 to 85 Percentage of the predicted at screening visit. 4. Participant on stable asthma therapy for at least 4 weeks before screening visit and as per investigators judgement have the ability to replace their current ICS or LABA or LAMA components in asthma medication with BDP, FFD, G. a. On medium or high doses of inhaled corticosteroids [ICS] Plus long-acting beta agonist [LABA] plus long acting muscarinic antagonist [LAMA] [fixed or free combination] OR b. On medium or high doses of ICS plus LABA [fixed or free combination] with not adequately controlled asthma as per GINA guideline [Appendix I] [medium and high dose ICS defined as beclometasone dipropionate non-extrafine Greater than 500, 1000 micro gm and Greater than 1000 micro gm respectively, or estimated clinical comparable dose]. 5. Participants who are willing and in the opinion of the investigator, are able to switch their current asthma therapy with study treatment. 6. Participant with Greater than or Equal to 12 percentage and Greater than 200mL reversibility of FEV1 approximately 15 minutes after four inhalations of salbutamol 100 micro gm per puff from pMDI at screening visit. 7. Currently non smoking having not used tobacco products [in other words cigarettes, cigars, pipe tobacco] within the past year, and having had Less than or Equal to 10 pack years of historical use. Note- The formula for pack years is Equal to [No. of cigarettes per day Divided by 20] multiply by No. of years smoked. 8. Male participant, if sexually active with a female of child-bearing potential must agree to use barrier method of contraception throughout the study period. 9. Female participant of child-bearing potential must follow acceptable forms of contraception throughout the study duration. 10. Participants who are willing to comply with all aspects of protocol and in the opinion of the investigator, are able to perform spirometry. 11. Participant willing to provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Known intolerance or hypersensitivity to corticosteroids, muscarinic antagonists, beta2 agonists or any components of pressurised metered dose inhaler. 2. Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway or lung disease. 3. Participant with a history of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder neck obstruction, or any other condition, which, in the opinion of the investigator, would contraindicate the use of an IP. 4. History of life threatening asthma defined as a significant asthma episode[s] requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode[s]. 5. Systemic corticosteroid use [e.g., prednisone for 3 or more days or a single depo-injectable dose of corticosteroids] for any respiratory, immune, or allergy attributed disease within 12 weeks prior to screening and randomisation visit. 6. An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to screening and randomisation visit. 7. A lower respiratory infection in the 4 weeks prior to screening and randomisation visit. 8. History of severe exacerbation or hospitalization for asthma within 6 months prior to screening visit. 9. Participant with a history of alcohol or substance or drug abuse within 12 months prior to screening visit. 10. Participant who has clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening. 11. QTc [Heart Rate Corrected QT interval] Greater Than 450 msec [male] or Greater Than 470 msec [female] or family history of long QT syndrome. QTc interval will be calculated with Bazetts Formula at screening visit. 12. Participant currently treated with non-potassium sparing diuretics [unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening], non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation. 13. Participant who has received an investigational drug within 1 month or 5 half lives [whichever is greater] prior to screening visit, or have been previously randomised in this trial, or are currently participating in another clinical trial. 14. Historical or current evidence of a clinically significant disease including, but not limited to hepatic, renal, haematological, neurological, endocrine, gastrointestinal, or pulmonary [Example like active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, COPD]. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the study analyses if the disease or condition exacerbated during the study. 15. Participant with known serum positivity for Hepatitis B, C or HIV. 16. Participant unable to with-hold medications as defined in the protocol for lung function study visits in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To evaluate the safety and effect of beclometasone dipropionate and formoterol fumarate dihydrate and glycopyrronium 172/5/9 mcg pressurized inhalation solution [HFO-1234ze [E]] and Trimbow 172/5/9 mcg pressurised inhalation solution [HFA-134a] over 12 weeks. Timepoint: 12 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary Endpoint: Number of participants with Treatment Emergent Adverse Events [TEAEs] Secondary Endpoints: a. Number of participants with Adverse Events [AEs] b. Number of participants with Serious Adverse Events [SAEs] Timepoint: 12 Weeks | — |
Countries
India
Contacts
Public ContactMr Devesh Verma
Cliantha Research Limited
Outcome results
None listed