A Study to determine Safety and Efficacy of Indacaterol/Glycopyrronium/Mometasone Furoate Inhalation Powder in Asthma Treatment
- Conditions
- Moderate persistent asthma, (2) ICD-10 Condition: J455||Severe persistent asthma,
- Registration Number
- CTRI/2025/03/083342
- Lead Sponsor
- Cipla Ltd
- Brief Summary
All patients willing to participate in the study will be required to give a written informed consent in the language understood by him/her. Patients will require a confirmed documented diagnosis of Asthma through spirometry.Patients not adequately controlled with a maintenance combination of long-acting beta 2 agonist and a high dose of an inhaled corticosteroid with history of one or more asthma exacerbations in last one year will be enrolled. Assessments of safety (adverse events), Spirometry (trough FEV1), asthma control questionnaire and quality of life, will be conducted at screening, baseline, week 6 and week 12
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 164
- Patients Greater than 18 years of age with a diagnosis of asthma, GINA 2024 for a period of at least 1 year prior to Screening.
- Patients not adequately controlled with a maintenance combination of long acting beta 2 agonist and a high dose of an inhaled corticosteroid.
- [High dose of ICS: Beclomethasone greater than 400mcg, Budesonide greater than 800mcg, fluticasone furoate greater than 200mcg, fluticasone propionate greater than 500mcg, mometasone furoate greater than 400mcg].
- Patient should be on high dose of ICS for at least one month prior to screening.
- ACQ-5 score greater than or equal to 1.5 at screening.
- History of one or more asthma exacerbations in last one year.
- Patients with pre-bronchodilator FEV1 less than 80% of the predicted normal value at screening.
- An increase in FEV1 of greater than or equal to 12% and 200 mL within 15 to 30 minutes after administration of 400 mcg salbutamol or 200mcg of levosalbutamol.
- Patients with acute exacerbation of asthma (acute condition) within past 3 months.
- Patients who smoked or inhaled tobacco products within 6 months prior to screening or who had a smoking history of greater than 10 pack-years.
- Received treatment with Triple therapy i.e. ICS/LABA/LAMA within past 6 months.
- Patients with history of uncontrolled diabetes and/or uncontrolled glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention.
- Patients with a history of myocardial infarction (confirmed clinically by the investigator) within the previous 12 months.
- Patients who have had a respiratory tract infection or asthma worsening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE). Baseline | Week 6 | week 12
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving a minimal clinically important difference (MCID) of a 0.5 units reduction in ACQ-5 from baseline at week 6 & week 12. Week 6 Mean change in trough FEV1 at week 6 & week 12 from baseline Week 6 Percentage of days without rescue medication usage Week 12 Mean change in ACQ-5 score at week 6 & 12 from baseline. Week 6 Proportion of patients with uncontrolled, partly controlled & well controlled asthma as per ACQ-5 at week 6 & week 12 Week 6 Proportion of patients achieving a MCID of 0.5 units increase in Mini AQLQ from baseline at week 6 & week 12. Week 6 Mean change in pre-dose morning & evening PEFR at week 6 & 12 from baseline week 6 Mean change in Mini AQLQ at week 12 from baseline. Week 12
Trial Locations
- Locations (11)
All India Institute of Medical Sciences Gorakhpur
🇮🇳Gorakhpur, UTTAR PRADESH, India
All India Institute of Medical Sciences, (AIIMS) New Delhi
🇮🇳Delhi, DELHI, India
All India Institute of Medical Sciences, (AIIMS) Patna
🇮🇳Patna, BIHAR, India
Deviratna Multispeciality Hospital
🇮🇳Pune, MAHARASHTRA, India
Dhiraj General Hospital & Sumandeep Vidyapeeth deemed to be university
🇮🇳Vadodara, GUJARAT, India
Excelcare Hospital
🇮🇳Jaipur, RAJASTHAN, India
GMERS Medical College and Hospital
🇮🇳Vadodara, GUJARAT, India
Lokmanya Tilak Municipal General Hospital, (LTMGH)
🇮🇳Mumbai, MAHARASHTRA, India
Rakshith Hospital
🇮🇳Chennai, TAMIL NADU, India
Sri Ramachandra Medical College, (SRMC)
🇮🇳Chennai, TAMIL NADU, India
Scroll for more (1 remaining)All India Institute of Medical Sciences Gorakhpur🇮🇳Gorakhpur, UTTAR PRADESH, IndiaDr Devesh SinghPrincipal investigator8285866138drdps.don@gmail.com