| CTRI Number |
CTRI/2025/12/098671 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study to asses safety and tolerability of Breztri aerosphere® in Indian patients with Chronic Obstructive Pulmonary Disease (COPD) |
|
Scientific Title of Study
|
A post-marketing phase IV, multicentre, prospective study to observe the safety and tolerability of Breztri aerosphereR containing a fixed dose combination of Budesonide 160 mcg/ Glycopyrronium 7.2 mcg/ Formoterol fumarate dihydrate 5 mcg in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| D5980L00017 Version 2.0 dated 27 Mar 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naveed Nazir Shah |
| Designation |
Prinicipal Investigator |
| Affiliation |
Government Chest Diseases Hospital |
| Address |
Department of Pulmonary Medicine, Government Chest Diseases Hospital, Buchwara, Dalgate, Srinagar- 190001, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190001
India |
| Phone |
9149016438 |
| Fax |
|
| Email |
naveednazirshah@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gagandeep Momi |
| Designation |
Therapy Area Lead-BBU |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
919205074255 |
| Fax |
|
| Email |
gagandeep.momi@astrazeneca.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
V V Niranjan Kumar |
| Designation |
Project Manager |
| Affiliation |
AstraZeneca Pharma India Ltd |
| Address |
Block N1 12th Floor Manyata Embassy Business Park Rachenahalli Outer Ring Road Bangalore Karnataka India 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
6281750951 |
| Fax |
|
| Email |
v.vniranjankumar@astrazeneca.com |
|
|
Source of Monetary or Material Support
|
| AstraZeneca Pharma India Ltd |
|
|
Primary Sponsor
|
| Name |
AstraZeneca Pharma India Ltd |
| Address |
Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, Bangalore, Karnataka, India – 560045 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh Mittal |
All India Institute of Medical Science |
Room No.2, Porta Cabin, 3rd Floor, New Pvt Ward, Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, New Delhi - 110029
New Delhi
DELHI |
9968859414
saurabh_kgmu@yahoo.co.in |
| Dr Sushant H Meshram |
Asian KHMC Multispeciality Hospita |
213, W High Court Rd, near Shankar Nagar Square, Dharampeth, Nagpur, Maharashtra 440010
Nagpur
MAHARASHTRA |
9860990379
drsushant.in@gmail.com |
| Dr Richa Gupta |
Christian Medical College Hospital |
Christian Medical College Hospital Ida Scudder road Vellore TamilNadu 632004
Vellore
TAMIL NADU |
9600771705
drricha21@gmail.com |
| Dr Ajay Kumar Verma |
Dr Ram Manohar Lohia Institute of Medical Science |
Vibhuti Khand Gomtinagar Lucknow UP 226010
Lucknow
UTTAR PRADESH |
9919788862
drajay21@gmail.com |
| Dr Naveed Nazir Shah |
Government Chest Diseases Hospital |
Department of Pulmonary Medicine, Buchwara, Dalgate, Srinagar- 190001, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR |
9149016438
naveednazirshah@yahoo.com |
| Dr Satyanarayana M |
Manipal Hospital |
Manipal Hospital 98 Old Airport Road Bangalore Karnataka 560017
Bangalore
KARNATAKA |
9741303009
satya.mysore@gmail.com |
| Dr Venkat Nagarjuna Maturu |
Yashoda Hospital |
Yashoda Healthcare Service Pvt. Ltd., Cyber Tower to JNTU Road, Hyderabad - 500084, Telangana
Hyderabad
TELANGANA |
9100935638
arjunjipmer@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee,Yashoda Academy of Medical Education & Research |
Approved |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breztri aerosphere® |
Breztri aerosphere® (Budesonide 160 mcg / Glycopyrronium 7.2 mcg / Formoterol fumarate dihydrate 5 mcg), Fixed-dose triple combination inhalation pMDI |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Patients with a physician-confirmed diagnosis of COPD
a. With a history of one severe COPD exacerbation or two or more moderate COPD exacerbations in the preceding 12 months (Please refer to 0 for the definition of COPD exacerbation.)
b. Post-bronchodilator FEV1 should be between greater than or equal to 30% to less than 80% predicted
Sex and Contraceptive/Barrier Requirements
Both adult male and female patients in the age group 18 years and above are allowed in the study.
a) Male participants:
• must agree to use adequate contraception (male condom with spermicide; sterile sexual partner; or female sexual partner who uses an intrauterine device with spermicide, a female condom with spermicide, a contraceptive sponge with spermicide, an intravaginal system, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives) from study entry through at least 3 months after the last dose of study drug.
b) Female participants:
i. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal)
ii.A urine pregnancy test must be negative at screening.
The childbearing potential has a negative urine pregnancy test at screening and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study (During screening).
a) Complete abstinence from intercourse (when it is preferred and the usual lifestyle of the patient) or
b) Implants of levonorgestrel inserted for at least 1 month before the study drug administration but not beyond the third successive year following insertion or
c) Injectable progestogen administered for at least 1 month before study drug administration; or
d) Oral contraceptive (combined or progestogen-only) administered for at least one monthly cycle before study drug administration; or
e) Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
f) An intrauterine device inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year or
g) Estrogenic vaginal ring; or
h) Percutaneous contraceptive patches.
Able to provide written informed consent
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
participants are excluded from the study if any of the following criteria apply:
1. Any pathology/underlying condition, which, in the Investigator’s opinion, may pose a risk to the patient’s participation in the study or may influence either the results of the study or the subject’s ability to participate in the study.
2.Chest X-ray within 14 days before screening must be acceptable to the investigator. Subjects who have a chest X-ray that reveals clinically significant abnormalities not believed to be due to the presence of COPD should not be included. A chest x-ray must be conducted if the most recent chest x-ray is not available at the time of screening.
3. Patients having moderate to severe exacerbations within 6 weeks before the Screening period.
4. Female patients who are pregnant or lactating or planning a family during the study period.
5. Patients with either a history of hypersensitivity to excipients of the study drug or drugs with a similar chemical structure or class to the study drug.
6. Patients participating in any current or future interventional trial during the study will not be enrolled in the current study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
to asses safety of Breztri aerosphere® by the estimation of percentage of patients with AEs, SAEs, and AEs leading to discontinuation of study drug
Percentage of patients with AEs, SAEs, and AEs leading to discontinuation of study drug
Nature, intensity, seriousness, and causal relationship to the study drug
|
Visit1 Week-2
Visit2 Week1
Visit3 Week4
Visit 4 Week8
Visit5 week12
Visit6 Week16
Visit7 Week 20
Visit8 Week24
Visit9 Week28
Visit10 Week32
Visit11 Week36
Visit12 week40
Visit13 Week44
Visit14 week48
Visit15 Week 52
Visit4 Day |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="166"
Sample Size from India="166"
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)
|
20/01/2026 |
| 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="2"
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
|
This Phase IV, multicentre, open-label, single-arm post-marketing
study (INDOS-B) is designed to evaluate the safety and tolerability of Breztri
Aerosphere® (budesonide/glycopyrronium/formoterol) in Indian patients with
moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Approximately
166 participants will be enrolled across about 10 clinical sites in India and the
participants will receive two actuations of Breztri Aerosphere® twice daily for
48 weeks, with a total study duration of 52 weeks including follow-up. Safety
will be assessed through the monitoring of adverse events, serious adverse
events, withdrawals due to adverse events, laboratory parameters, vital signs,
ECGs, and spirometry. The study aims to generate long-term real-world evidence
on the safety profile of Breztri Aerosphere® in the Indian COPD population. |