| CTRI Number |
CTRI/2025/03/083342 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study to determine Safety and Efficacy of Indacaterol/Glycopyrronium/Mometasone Furoate Inhalation Powder in Asthma Treatment |
|
Scientific Title of Study
|
A Phase IV study to evaluate safety and efficacy of FDC of Indacaterol 150 mcg + Glycopyrronium 50 mcg + Mometasone Furoate IP 160 mcg powder for inhalation in patients with Asthma |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CP/03/24 Version 1 Dated 09/05/24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jaideep Gogtay |
| Designation |
Executive Global Chief Medical Officer |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025145 |
| Fax |
|
| Email |
jgogtay@cipla.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Sawant |
| Designation |
Head- Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. NA, 289 Bellasis Road, Mumbai Central, Mumbai- 400008 Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025006 |
| Fax |
|
| Email |
sandesh.sawant3@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Abhijit Vaidya |
| Designation |
Associate Director, Clinical Trials |
| Affiliation |
Cipla Limited |
| Address |
Cipla Ltd, Dept: Medical Services, Division: Clinical Trials, Room No. No 289 Bellasis Road, Mumbai Central, Mumbai 400008 Maharashtra India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02223025623 |
| Fax |
|
| Email |
abhijit.vaidya@cipla.com |
|
|
Source of Monetary or Material Support
|
| Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
|
|
Primary Sponsor
|
| Name |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai, Maharashtra, 400008, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Devesh Singh |
All India Institute of Medical Sciences Gorakhpur |
room no 206 & 207, Department of Pharmacology and Therapeutics, OPD building, AIIMS Kunraghat, Gorakhpur, Uttar Pradesh 273008
Gorakhpur
UTTAR PRADESH |
91 8285866138
drdps.don@gmail.com |
| Dr Anant Mohan |
All India Institute of Medical Sciences, (AIIMS) New Delhi |
Room No. 5 3rd floor Porta cabin New Private ward, department of PCCSM, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029
New Delhi
DELHI |
9810048204
anantmohan@yahoo.com |
| Dr Saurabh Karmakar |
All India Institute of Medical Sciences, (AIIMS) Patna |
OPD Building Room No 330, Department of Pulmonary Medicine AIIMS Patna - Aurangabad Rd, Phulwari Sharif, Patna, Bihar 801507
Patna
BIHAR |
9839443375
drsaurabhkarmakar@gmail.com |
| Dr Vaibhav Pandharkar |
Deviratna Multispeciality Hospital |
OPD No. 6, Ground floor, 45 A/1B, Nagar Rd, next to Inorbit Mall, Somnath Nagar, Wadgaon Sheri, Pune, Maharashtra 411014
Pune
MAHARASHTRA |
9923111646
drvaibhavpandharkar@gmail.com |
| Dr Arti Shah |
Dhiraj General Hospital & Sumandeep Vidyapeeth deemed to be university |
OPD No 215 Ground Floor - Block B Dhiraj Hospital
Sumandeep Vidyapeeth Deemed to be University
At & Po Piparia, Ta Waghodia, Vadodara 391760
Gujarat, India
Vadodara
GUJARAT |
9925747880
artidhawal76@gmail.com |
| Dr Sanjay Khator |
Excelcare Hospital |
Clinical Research Division, Room No. 301, 3rd Floor, 103, Sanjay Nagar A, Joshi Marg Kalwar Road, Jhotwara Jaipur
Jaipur
RAJASTHAN |
9314524056
sanjaykhator71@gmail.com |
| Dr Anand Patel |
GMERS Medical College and Hospital |
OPD no 206, Department of respiratory medicine 2nd floor GMERS, Gotri Rd, Gotri, Vadodara, Gujarat 390021
Vadodara
GUJARAT |
91 9879771079
anand.trials@gmail.com |
| Dr Jairaj Nair |
Lokmanya Tilak Municipal General Hospital, (LTMGH) |
Department of Respiratory Medicine, Room No. 12, first floor College building, Lokmanya Tilak Municipal Medical College and General Hospital, Sion Mumbai 400022
Mumbai
MAHARASHTRA |
8898816660
dr.jairaj.p.nair@gmail.com |
| Dr Santhalingam BalaMurugan |
Rakshith Hospital |
152, Arcot Road, Sai square complex (opposite to sivan kovil temple), Valasaravakkam, Chennai, Tamil Nadu-600 087
Chennai
TAMIL NADU |
9600002646
dr.s.bala@gmail.com |
| Dr Mansi Gupta |
Sanjay Gandhi Postgraduate Institute of Medical Science (SGPGI, Lucknow) |
Room No. 4, 2nd Floor, Pulmonary Medicine OPD, New OPD block, SGPGIMS, Raebareli Road, Lucknow 226014
Lucknow
UTTAR PRADESH |
9870047866
mansi1712@gmail.com |
| Dr Dhanasekar T |
Sri Ramachandra Medical College, (SRMC) |
G Block, Department of Chest and TB, room no 4, Professor and HOD department of Respiratory Medicine SRMC Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
8939133393
drdhanasekar@yahoo.com |
| Dr Rohit Kumar |
Vardhaman Mahavir Medical College & Safdarjung Hospital and Safdarjung Hospital (VMMC & Sufdarjung) |
Room No 662 6th floor department of pulmonary critical care sleep medicine SSB building VMMC Safdarjung hospital, Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi 110029
New Delhi
DELHI |
9911218081
dr.rohitkumar@mail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 12 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee-CIEC (Dr. Vaibhav Pandharkar) |
Approved |
| IEC Sardarmal Khandaka Memorial Hospital (Dr. Sanjay Khator) |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences (AIIMS New Delhi - Dr. Anant Mohan) |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences (AIIMS Patna- Dr. Saurabh Karmakar) |
Approved |
| Institutional Ethics Committee for Human Research, LTMMC (Dr. Jairaj Nair) |
Approved |
| Institutional Ethics Committee of Sanjay gandhi Postgraduate Institute of Sciences |
Approved |
| Institutional Ethics Committee SRIHER (Dr. Dhanasekhar T.) |
Approved |
| Institutional Ethics committee Vardhaman Mahavir Medical College & Safdarjung Hospital (Dr. Rohit Kumar) |
Submittted/Under Review |
| Institutional Human Ethics Committee (AIIMS Gorakhpur-Dr. Devesh Singh) |
Approved |
| Institutional Human Ethics Committee GMERS Medical College and Hospital (Dr. Anand Patel) |
Submittted/Under Review |
| Ripon Independent Ethics Committee (Dr. S. Balamurugan) |
Approved |
| Sumandeep Vidyapeeth Institutional Ethics Committee (Dr. Arti Shah) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, (2) ICD-10 Condition: J455||Severe persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Indacaterol 150 mcg + Glycopyrronium 50 mcg + Mometasone Furoate IP 160 mcg powder for inhalation |
powder for inhalation, one capsule once daily. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. 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.
2. 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.
3. ACQ-5 score greater than or equal to 1.5 at screening.
4. History of one or more asthma exacerbations in last one year.
5. Patients with pre-bronchodilator FEV1 less than 80% of the predicted normal value at screening.
6. 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.
|
|
| ExclusionCriteria |
| Details |
1. Patients with acute exacerbation of asthma (acute condition) within past 3 months.
2. 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.
3. Received treatment with Triple therapy i.e. ICS/LABA/LAMA within past 6 months.
4. 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.
5. Patients with a history of myocardial infarction (confirmed clinically by the investigator) within the previous 12 months.
6. Patients with a documented history of chronic lung diseases other than asthma,
7. Patients who have had a respiratory tract infection or asthma worsening
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE). |
Baseline
Week 6
week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in trough FEV1 at week 6 & week 12 from baseline |
Week 6
week 12 |
| Mean change in pre-dose morning & evening PEFR at week 6 & 12 from baseline |
week 6
week 12 |
| Mean change in ACQ-5 score at week 6 & 12 from baseline. |
Week 6
week 12 |
| Proportion of patients with uncontrolled, partly controlled & well controlled asthma as per ACQ-5 at week 6 & week 12 |
Week 6
week 12 |
| 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
week 12 |
| Percentage of days without rescue medication usage |
Week 12 |
| Mean change in Mini AQLQ at week 12 from baseline. |
Week 12 |
| Proportion of patients achieving a MCID of 0.5 units increase in Mini AQLQ from baseline at week 6 & week 12. |
Week 6
week 12 |
|
|
Target Sample Size
|
Total Sample Size="164"
Sample Size from India="164"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |