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CTRI Number  CTRI/2025/10/096069 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 13/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   A study to find out whether BI 1291583 helps people with bronchiectasis 
Scientific Title of Study   A Phase III, randomised, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of BI 1291583 2.5 mg administered once daily for up to 76 weeks in patients with bronchiectasis (The AIRTIVITY® Study) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1397-0014 Version 1.0, 29 Jan 2025  Protocol Number 
2024-518589-29  EudraCT 
U1111-1317-2315  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli

Bangalore
KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Details of Contact Person
Public Query  
Name  Shweta Pradhan 
Designation  Head Clinical Operations 
Affiliation  IQVIA RDS (India) Private Limited 
Address  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli


KARNATAKA
560103
India 
Phone  9513774664  
Fax    
Email  shweta.pradhan@iqvia.com  
 
Source of Monetary or Material Support  
Boehringer Ingelheim International GmbH 
 
Primary Sponsor  
Name  Boehringer Ingelheim International GmbH 
Address  Binger Str. 173, 55218 Ingelheim am Rhein,Germany 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
IQVIA RDS India Private Limited  Omega Embassy Tech Square, Marathahalli - Sarjapura, Outer Ring Road, Kadubeesanahalli, Bengaluru, Karnataka, 560103, India 
 
Countries of Recruitment     Argentina
Australia
Austria
Belgium
Brazil
Bulgaria
Canada
Chile
China
Croatia
Czech Republic
Denmark
Egypt
Finland
France
Germany
Greece
Hong Kong
Hungary
India
Ireland
Israel
Italy
Japan
Kazakhstan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Zealand
Philippines
Poland
Portugal
Republic of Korea
Romania
Serbia
Singapore
Slovakia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
United Kingdom
United States of America
Viet Nam  
Sites of Study  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samada rshi Datta  B.P. Poddar Hospital & Medical Research Ltd,  71/1, Humayu n Kabir Sarani, Block G, New Alipore - 700053
Kolkata
WEST BENGAL 		 9830253734

samadoc@gmail.com 
Dr Raghumanda Sunil Kumar  Government Hospital for Chest and Communicable Diseases (GHCCD)  Andhra Medical College, Pedda Waltair 530017
Visakhapatnam
ANDHRA PRADESH 		 9849126543

drrsunilkumarresearch@gmail.com 
Dr Piyush Arora  Jawahar Lal Nehru Medical College  Kala Bagh - 305001
Ajmer
RAJASTHAN 		 8118877284

Clinical.jln@gail.com 
Dr Prasanna Kumar T  M S Ramaiah Medical College and Hospitals  M S Ramaiah Nagar, MSRIT Post, 560054
Bangalore
KARNATAKA 		 9902708710

prasannakumart.rmc@msruas.ac.in 
Dr Murali Mohan BV  Mazumdar Shaw Medical Center- a unit of Narayan a Hrudayalaya Limited  No. 258/A, Bommas andra Industria l Area, Anekal Taluk- 560090
Bangalore
KARNATAKA 		 9844097170

muralimohan.bv.dr@narayanahealth.org 
Dr Bhanu Pratap Singh  Midland healthcare and research center  B 55 & C 42 Mandir Marg Maha nagar extension 226006
Lucknow
UTTAR PRADESH 		 9415011669

bps2159@yahoo.com 
Dr Pawan Kumar Singh  Pt. B.D Sharma Post Graduat e Institute of Medical Sciences  Near Delhi Bye Pass 124001
Rohtak
HARYANA 		 8437013094

ga.ps.complete@gmail.com 
Dr Abhina ndan Bhikch and Mutha  Siddhi Hospital  C/o. Dr Mutha Hospital, P-67, MIDC, Satpur, Behind ITI, Near PF Office Trimbak Road 422007
Nashik
MAHARASHTRA 		 0253- 2353377

abhimutha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
BP Poddar And ParvatiDevi Foundation For Education_Dr. Samadarshi Datta  Approved 
Ethics committee_ Dr. Prasanna Kumar T  Submittted/Under Review 
IEC, Midland healthcar e and research center_Dr Bhanu Pratap Singh  Approved 
Institutional Ethics Committee _Dr. Pawan Kumar Singh  Approved 
Institutional Ethics Committee, King George Hospital_ Dr Raghumanda Sunil Kumar  Approved 
Institutional Ethics Committee_Dr. Piyush Arora  Approved 
Narayana Health Medical Ethics Committee_Dr. Murali Mohan BV  Approved 
Siddhi Hospital Institutional Ethics Committee_Dr. Abhinandan Bhikchand Mutha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J47||Bronchiectasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BI 1291583   Dose: 2.5 mg Route: oral Frequency: 1 tablet daily  
Comparator Agent  Placebo to BI 1291583 film-coated tablets   Dose: matching placebo Route: oral Frequency: 1 tablet daily  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female participants
WOCBP1 must be ready and able to use highly effective methods of birth control per ICH
M3 (R2) that result in a low failure rate of less than 1percent per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting
these criteria is provided in the participant information.
2. Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation.
3. Age of participants when signing the informed consent more than equals to 18 (at least the legal age of consent in countries where it is greater than 18 years) years.
4. Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production,
recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years.
5. Participants should be able to produce sputum for screening (see the SOA).
6. History of documented pulmonary exacerbations requiring antibiotic treatment. In the
12 months before Visit 1, participants must have had either:
a. at least 2 exacerbations, or
b. at least 1 exacerbation and an SGRQ Symptoms score of more than 40 at screening Visit 1
For participants on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of stable antibiotics or CFTR-MT. 
 
ExclusionCriteria 
Details  1. Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or
C hepatic impairment).
2. An absolute blood neutrophil count more than 1,000/mm3 (equivalent to more than 1,000 cells/micro L or more than 109
Cells per L) at Visit 1.
3. eGFR according to CKD-EPI formula more than 30 mL per min at Visit 1.
4. Total IgG levels more than 5g per l at Visit 1.
5. Any findings in the medical examination and or laboratory value assessed at Screening
Visit 1 or during screening period, that in the opinion of the investigator may put the
participant at risk by participating in the trial. (Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomisation. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the participant remains in the trial. The justification for decision needs to be documented).
6. Relevant chronic or acute infections including but not limited to HIV and viral hepatitis.
The corresponding laboratory tests will be performed during screening. Criteria for assessment of exclusionary lab tests for HIV and viral hepatitis 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To demonstrate superiority of BI 1291583 2.5 mg compared to placebo on the primary endpoint, the annualized rate of adjudicated pulmonary exacerbations in participants with bronchiectasis  Week 76 
 
Secondary Outcome  
Outcome  TimePoints 
To demonstrate a reduction in lung function decline as measured by the change from baseline in FEV1 %pred and FVC %pred, an improvement in the respiratory symptoms as measured by the absolute change from baseline in QOL-B respiratory symptoms score, a risk reduction in pulmonary exacerbations and a reduction in the annualized rate of severe pulmonary exacerbations for BI 1291583 2.5 mg when compared to placebo  Week 76 
 
Target Sample Size   Total Sample Size="1680"
Sample Size from India="30" 
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 3 
Date of First Enrollment (India)   28/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/07/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The intent of this study is to evaluate the efficacy, safety, and tolerability of BI 1291583 2.5 mg q.d. compared to placebo in participants with bronchiectasis independent of underlying etiologies. The ability of BI 1291583 2.5 mg in reducing the number of pulmonary exacerbations over a treatment period of at least 52 weeks and up to 76 weeks along with a favourable benefit-risk ratio in patients with bronchiectasis will be investigated. 
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