| CTRI Number |
CTRI/2025/10/096147 [Registered on: 16/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
real world study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of patient satisfaction, ease of training and clinical effectiveness of ICS-LABA combinations (in asthma patients) delivered through Ciphaler® |
|
Scientific Title of Study
|
Assessment of patient satisfaction ease of training and clinical effectiveness of ICS-LABA combinations delivered through Ciphaler A real world observational study in patients with asthma CONTROL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sundeep Salvi |
| Designation |
Director |
| Affiliation |
Chest Research and Training Private Limited |
| Address |
Dept of Research, Directors Chamber, First Floor, Faith Center Lane No 4 Survey No 232 Plot No 82 Sakorenagar, Vimannagar, Pune
Pune
MAHARASHTRA
411014
India |
| Phone |
9921211000 |
| Fax |
|
| Email |
sundeepsalvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meena Lopez |
| Designation |
Head Medical Services – Respiratory |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02246185000 |
| Fax |
|
| Email |
meena@cipla.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Naik |
| Designation |
Senior Manager – Medical Affairs |
| Affiliation |
Cipla Ltd |
| Address |
Cipla Ltd, 289 Bellasis Road, Mumbai Central, Mumbai Maharashtra, India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
02246185000 |
| Fax |
|
| Email |
vaishali.naik@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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Salvi |
Chest Research and Training Private Limited |
Dept of Research, Directors Chamber, First Floor, Faith Center, Lane No 4, Survey No 232, Plot No 82, Sakore Nagar, Viman Nagar, Pune - 411014
Pune
MAHARASHTRA |
9921211000
sundeepsalvi@gmail.com |
| Dr Murali Mohan BV |
Mazumdar Shaw Medical Center – Unit of Narayana Hrudayalaya Limited |
258/A, Bommasandra Industrial Area, Anekal Taluk, Bengaluru, Karnataka - 560099
Bangalore
KARNATAKA |
9844097170
muralimohan.bv.dr@narayanahealth.org |
| Dr Randeep Guleria |
Medanta – The Medicity |
Sector – 38, Gurugram, Haryana – 122001, India
Gurgaon
HARYANA |
9810184738
randeepguleria2002@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee |
Approved |
| Medanta Institutional Ethics Committee |
Submittted/Under Review |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J45||Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1 Either gender, of age 18 years or above, with documented diagnosis of Asthma (as per GINA 2025)
2 Prescribed treatment with ICS-LABA delivered through the Ciphaler® based on investigator discretion
3 Willing for follow-up at scheduled visit as per protocol
4 A voluntarily given written, signed, dated informed consent from participants and/or legally acceptable representative
|
|
| ExclusionCriteria |
| Details |
1 Hypersensitivity to the study drug or any of its components
2 Life-threatening or unstable respiratory disease, including lower respiratory tract infection, within the past 4 weeks from screening
3 Acute episodes of asthma requiring systemic corticosteroids, emergency care or hospitalization in the 30 days prior to Baseline visit
4 Chronic pulmonary diseases other than asthma such as COPD, post-tuberculosis lung disease, pulmonary fibrotic disease, or pulmonary arterial hypertension
5 Severe asthma patients receiving biologicals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient satisfaction |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ease of training with Ciphaler®
|
Baseline |
| 2. Change in ACQ-5 score |
Baseline
Week 8 |
| 3. Change in ACQ-5 score categories as well controlled (ACQ-5 less than 0.75), partially controlled (ACQ-5 more than 0.75 to less than 1.5), and uncontrolled (ACQ-5 more than 1.5) |
Baseline
week 8 |
| 4. Adverse Event |
Through Study |
|
|
Target Sample Size
|
Total Sample Size="2500"
Sample Size from India="2500"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2025 |
| 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
|
Drugs administered through the inhaled route have become very important for the treatment of respiratory diseases like asthma. This is a real-world, observational study to assess patient satisfaction, ease of training and clinical effectiveness of ICS-LABA combinations delivered through Ciphaler® in patients with asthma. |