The AIRTIVITY® Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
Launched by BOEHRINGER INGELHEIM · Mar 7, 2025
Trial Information
Current as of July 03, 2025
Recruiting
Keywords
ClinConnect Summary
The AIRTIVITY® Study is a clinical trial that aims to find out if a medication called BI 1291583 can help adults with bronchiectasis, a condition that affects the lungs and often leads to coughing and producing mucus. To be eligible for this study, participants must be 18 years or older, have a confirmed diagnosis of bronchiectasis, and have experienced flare-ups, or exacerbations, in the past year that required antibiotics. Those who are pregnant or have certain medical conditions may not be able to join.
If you participate in this study, you will be randomly placed into one of two groups: one will take the BI 1291583 tablets, and the other will take a placebo (a tablet that looks the same but has no active medicine). You will take one tablet each day for up to a year and a half. Throughout the study, you'll visit the study site up to 10 times and receive phone calls to check on your health. You will also keep a daily diary on your smartphone about your symptoms. The goal is to see how BI 1291583 affects the number of flare-ups compared to the placebo and to monitor any side effects. This study is not yet recruiting participants, but it is an important step in finding new treatments for bronchiectasis.
Gender
ALL
Eligibility criteria
- Inclusion criteria:
- • Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % 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.
- • Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
- • Age of participants when signing the informed consent ≥18 (at least the legal age of consent in countries where it is greater than 18 years) years.
- • Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by Computed Tomography (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.
- • Participants should be able to produce sputum for screening.
- * History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either:
- • at least 2 exacerbations, or
- • at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 For participants on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of stable antibiotics or CFTR-MT.
- Exclusion criteria:
- • Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- • Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- • Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- • 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.
- • Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2.
- • Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study.
- • Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
- • Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix.
- • Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment).
- • estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30 mL/min at Visit 1.
- • Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Cleveland, Ohio, United States
Charleston, South Carolina, United States
Madison, Wisconsin, United States
Iowa City, Iowa, United States
Saint Louis, Missouri, United States
Tampere, , Finland
Bangkok, , Thailand
Jackson, Mississippi, United States
Anderson, South Carolina, United States
Galveston, Texas, United States
Miami, Florida, United States
Omaha, Nebraska, United States
Rozzano (Mi), , Italy
Washington, District Of Columbia, United States
Cincinnati, Ohio, United States
London, , United Kingdom
Singapore, , Singapore
Singapore, , Singapore
Seattle, Washington, United States
Barcelona, , Spain
Badalona, , Spain
Madrid, , Spain
Chapel Hill, North Carolina, United States
Singapore, , Singapore
Weston, Florida, United States
Bangkok, , Thailand
Gainesville, Florida, United States
New York, New York, United States
Hannover, , Germany
Genova, , Italy
Taipei, , Taiwan
Worcester, Massachusetts, United States
Rochester, Minnesota, United States
Frankfurt, , Germany
Baltimore, Maryland, United States
New Haven, Connecticut, United States
L'hospitalet De Llobregat, , Spain
Southampton, , United Kingdom
Madrid, , Spain
Sevilla, , Spain
Basel, , Switzerland
Belfast, , United Kingdom
Khon Kaen, , Thailand
Barcelona, , Spain
Odense C, , Denmark
Badalona, , Spain
Hvidovre, , Denmark
Atlanta, Georgia, United States
Portland, Oregon, United States
Utrecht, , Netherlands
Beijing, , China
Lancaster, , United Kingdom
Seoul, , Korea, Republic Of
Taichung, , Taiwan
Edinburgh, , United Kingdom
Blackpool, , United Kingdom
Richmond, Virginia, United States
London, , United Kingdom
Edinburgh, , United Kingdom
Münster, , Germany
Helsinki, , Finland
Bradford, , United Kingdom
Sheffield, , United Kingdom
Halifax, Nova Scotia, Canada
Berlin, , Germany
Kaohsiung, , Taiwan
Leuven, , Belgium
Patumwan, , Thailand
Augusta, Georgia, United States
Genova, , Italy
Barcelona, , Spain
Sevilla, , Spain
Calgary, Alberta, Canada
Seoul, , Korea, Republic Of
Kuching, , Malaysia
Freiburg, , Germany
Sevilla, , Spain
Santander, , Spain
Girona, , Spain
Chengdu, , China
Wuhan, , China
Tyler, Texas, United States
Monterrey, , Mexico
Seoul, , Korea, Republic Of
Pavia, , Italy
Birmingham, , United Kingdom
Calgary, Alberta, Canada
Zagreb, , Croatia
El Palmar, , Spain
Immenhausen, , Germany
Gauting, , Germany
Changchun, Jilin, China
Colchester, Vermont, United States
Sacramento, California, United States
Shanghai, , China
Hong Kong, , Hong Kong
San Juan, , Puerto Rico
Jena, , Germany
Innsbruck, , Austria
Lausanne, , Switzerland
Beijing, Beijing, China
Bruxelles, , Belgium
Chengdu, , China
Halle/Saale, , Germany
Thessaloniki, , Greece
Aarhus N, , Denmark
Parkville, Victoria, Australia
Mainz, , Germany
Birmingham, Alabama, United States
Leeds, , United Kingdom
Berlin, , Germany
Seoul, , Korea, Republic Of
Gent, , Belgium
Roma, , Italy
Hokkaido, Sapporo, , Japan
Kanagawa, Yokohama, , Japan
Okayama, Kurashiki, , Japan
Songkla, , Thailand
Shanghai, , China
Jacksonville, Florida, United States
Halle, , Germany
Seoul, , Korea, Republic Of
Liverpool, , United Kingdom
Yangzhou, , China
Guangzhou, , China
Huelva, , Spain
Nanjing, , China
Montpellier, , France
Essen, , Germany
Beijing, , China
Hefei, Anhui, China
Changsha, , China
Pamplona, , Spain
Ventura, California, United States
Riga, , Latvia
Suzhou, Jiangsu, China
Kiel, , Germany
Tokyo, Itabashi Ku, , Japan
Seoul, , Korea, Republic Of
Quezon City, , Philippines
Nanjing, , China
Nis, , Serbia
Torquay, , United Kingdom
Murray, Utah, United States
Nanchang, , China
Seoul, , Korea, Republic Of
Köln, , Germany
Huelva, , Spain
Padova, , Italy
New Brunswick, New Jersey, United States
Hangzhou, , China
Qingdao, , China
Fukuoka, Iizuka, , Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kaohsiung, , Taiwan
Paris, , France
A Coruña, , Spain
Palma De Mallorca, , Spain
Stoke On Trent, , United Kingdom
Chesterfield, Missouri, United States
Nanchang, , China
Bamberg, , Germany
Aichi, Nagoya, , Japan
Miyagi, Sendai, , Japan
Saitama, Kumagaya, , Japan
Dortmund, , Germany
Altamonte Springs, Florida, United States
Nantong, , China
Sremska Kamenica, , Serbia
Berlin, , Germany
Beijing, Beijing, China
Atlanta, Georgia, United States
Jacksonville, Florida, United States
Amiens, , France
Pessac, , France
Fukuoka, Fukuoka, , Japan
Rock Hill, South Carolina, United States
Suining, , China
Cheongju Si, , Korea, Republic Of
Falls Church, Virginia, United States
Kuala Lumpur, , Malaysia
Athens, , Greece
Oviedo, , Spain
Prague, , Czechia
Nuevo León, , Mexico
Porto Alegre, , Brazil
Montreal, Quebec, Canada
Xi'an, , China
Seoul, , Korea, Republic Of
Alor Setar, , Malaysia
Heidelberg, , Germany
Iloilo, , Philippines
Shenzhen, , China
Shanghai, , China
Alkmaar, , Netherlands
Oulu, , Finland
Nijmegen, , Netherlands
New York, New York, United States
New Hyde Park, New York, United States
Bonn, , Germany
Heraklion, Crete, , Greece
Aomori, Hirosaki, , Japan
Chiba, Chiba, , Japan
Kyoto, Kyoto, , Japan
Tokyo, Shinjuku Ku, , Japan
New York, New York, United States
Guangzhou, , China
Hangzhou, , China
Patras, , Greece
Fukuoka, Fukuoka, , Japan
Nagasaki, Nagasaki, , Japan
Mie, Matsusaka, , Japan
Tokyo, Minato Ku, , Japan
Quebec, , Canada
Cork, , Ireland
Verona, , Italy
Frankfurt, , Germany
Santiago De Compostela, , Spain
Wonju Si, , Korea, Republic Of
Dresden, , Germany
Anyang, , Korea, Republic Of
Nice, , France
Caba, , Argentina
Seoul, , Korea, Republic Of
New York, New York, United States
Buenos Aires, , Argentina
Talca, , Chile
Osaka, Sakai, , Japan
Shizuoka, Hamamatsu, , Japan
Tokushima, Tokushima, , Japan
Rzeszow, , Poland
Valencia, , Spain
Shizuoka, Hamamatsu, , Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
High Heaton, , United Kingdom
Kagoshima, Kagoshima, , Japan
Seoul, , Korea, Republic Of
Bialystok, , Poland
Pozuelo De Alarcón, , Spain
Newport Beach, California, United States
San Antonio, Texas, United States
Tokyo, Shinjuku Ku, , Japan
Seoul, , Korea, Republic Of
Dundee, Scotland, , United Kingdom
Shanghai, , China
Cardiff, , United Kingdom
Zutphen, , Netherlands
San Antonio, Texas, United States
Tianjin, , China
Incheon, , Korea, Republic Of
Barcelona, , Spain
Vidin, , Bulgaria
Alberdi Sur, , Argentina
Hangzhou, , China
Goiânia, , Brazil
Shenyang, , China
Pecs, , Hungary
Amsterdam, , Netherlands
Den Haag, , Netherlands
Philadelphia, Pennsylvania, United States
Yunlin County, , Taiwan
Clearwater, Florida, United States
Cypress, Texas, United States
Mérida, , Spain
Shanghai, , China
Caguas, , Puerto Rico
Taoyuan, , Taiwan
Seoul, , Korea, Republic Of
Saint Herblain, , France
Shanghai, , China
Messina, , Italy
Verona, , Italy
Ibaraki, Tsukuba, , Japan
Shiga, Otsu, , Japan
Alor Setar, Kedah, , Malaysia
Kaunas, , Lithuania
The Villages, Florida, United States
Bochum, , Germany
Huzhou, , China
Pingxiang, , China
Palma De Mallorca, , Spain
Hangzhou, , China
Montreal, Quebec, Canada
Iloilo City, , Philippines
Stockholm, , Sweden
Athens, , Greece
Tlalnepantla, , Mexico
Burlington, Ontario, Canada
Huntersville, North Carolina, United States
Kragujevac, , Serbia
Uzice, , Serbia
Jeollabuk Do, , Korea, Republic Of
Cypress, Texas, United States
East Kilbride, , United Kingdom
Jena, , Germany
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
El Paso, Texas, United States
Caba, , Argentina
Chengdu, , China
Niigata, Niigata, , Japan
Saga, Saga, , Japan
Seoul, , Korea, Republic Of
Botucatu, , Brazil
Yamaguchi, Ube, , Japan
Chihuahua, , Mexico
Wuxi, , China
Ningbo, , China
Seoul, , Korea, Republic Of
ålborg, , Denmark
Riga, , Latvia
Riga, , Latvia
Piaseczno, , Poland
Créteil, , France
Cádiz, , Spain
Vejle, , Denmark
Istanbul, , Turkey
Graz, , Austria
Mckinney, Texas, United States
Bologna, Bo, Italy
Kuala Lumpur, , Malaysia
Tokyo, Kiyose, , Japan
Osaka, Toyonaka, , Japan
Ann Arbor, Michigan, United States
Mérida, , Spain
Chiba, Kamogawa, , Japan
Hangzhou, , China
Dublin 15, , Ireland
Cape Town, , South Africa
Mar Del Plata, , Argentina
Quilmes, , Argentina
Cambridge, , United Kingdom
Rennes, , France
Jerez De La Frontera, , Spain
Rosario, , Argentina
Ningbo, , China
Winnipeg, Manitoba, Canada
Petach Tikva, , Israel
Daugavpils, , Latvia
Jurmala, , Latvia
Vilnius, , Lithuania
Lille, , France
Rijeka, , Croatia
Kajang, , Malaysia
Lisboa, , Portugal
Bend, Oregon, United States
Leiria, , Portugal
Vila Nova De Gaia, , Portugal
Aveiro, , Portugal
Guimarães, , Portugal
Napoli, , Italy
Jiangmen, , China
München, , Germany
Coimbra, , Portugal
Braga, , Portugal
Astana, , Kazakhstan
Redding, California, United States
Wonju Si, Gangwon State, , Korea, Republic Of
Dubois, Pennsylvania, United States
Xuzhou, , China
Ciudad Autonoma Buenos Aires, , Argentina
Caba, , Argentina
Tokyo, Bunkyo Ku, , Japan
Daugavpils, , Latvia
Donaustauf, , Germany
Ho Chi Minh City, , Vietnam
Rotterdam, , Netherlands
Hong Kong, , Hong Kong
Caba, , Argentina
Singapore, , Singapore
Lübeck, , Germany
Sao Bernardo Do Campo, , Brazil
Vancouver, British Columbia, Canada
Jilin, , China
Mount Edgecombe, , South Africa
Trois Rivieres, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Milano, , Italy
Rohtak, , India
Istanbul, , Turkey
Guiyang, , China
Zhejiang, , China
Dresden, , Germany
Ruse, , Bulgaria
Astana, , Kazakhstan
Lyon, , France
Ahrensburg, , Germany
Palermo, , Italy
Nice, , France
L'hospitalet De Llobregat, , Spain
Warszawa, , Poland
Roma, , Italy
Phoenix, Arizona, United States
Newport Beach, California, United States
Naples, Florida, United States
Hawthorne, New York, United States
San Antonio, Texas, United States
Bahia Blanca, , Argentina
Caba, , Argentina
Santa Fe, , Argentina
Wels, , Austria
Sint Niklaas, , Belgium
João Pessoa, , Brazil
Pernik, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Veliko Tarnovo, , Bulgaria
Vratsa, , Bulgaria
Región Metropolitana, , Chile
Jindrichuv Hradec, , Czechia
Prague, , Czechia
Turku, , Finland
Tououse, , France
Halle (Saale), , Germany
Halle/Saale, , Germany
Köln, , Germany
Potsdam, , Germany
Stralstund, , Germany
Budapest, , Hungary
Visakhapatnam, , India
Jerusalem, , Israel
Monza (Mb), , Italy
Kyoto, Joyo, , Japan
Shimane, Matsue, , Japan
Daegu, , Korea, Republic Of
Gangdong Gu, , Korea, Republic Of
Riga, , Latvia
Klaipeda, , Lithuania
Vilnius, , Lithuania
Vilnius, , Lithuania
Mexico City, , Mexico
Mandaluyong City, , Philippines
Taft, Manila, , Philippines
Chorzow, , Poland
Piaseczno, , Poland
Wolomin, , Poland
Porto, , Portugal
Bucharest, , Romania
Cluj Napoca, , Romania
Cluj Napoca, , Romania
Timisoara, , Romania
Belgrade, , Serbia
Kosice, , Slovakia
Martin, , Slovakia
Spišská Nová Ves, , Slovakia
Uppsala, , Sweden
örebro Län, , Sweden
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Ho Chi Minh City, , Vietnam
Saint Paul, Minnesota, United States
Cairo, , Egypt
Halle, , Germany
Berlin, , Germany
Chesterfield, Missouri, United States
Santiago De Chile, , Chile
Changchun, , China
Jinan, , China
Quanzhou, , China
Shanghai, , China
Wenzhou, , China
Yixing, , China
Dong Gu Ulsan, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kelantan, , Malaysia
Wp Kuala Lumpur, , Malaysia
Wolomin, , Poland
Bucharest, , Romania
Kosice, , Slovakia
Spišská Nová Ves, , Slovakia
Ho Chi Minh City, , Vietnam
Cairo, , Egypt
Wiesbaden, , Germany
Hyogo, Himeji, , Japan
Oita, Yufu, , Japan
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Alor Setar, Kedah, , Malaysia
Cape Town, , South Africa
Sherbrooke, Quebec, Canada
Anchorage, Alaska, United States
Naples, Florida, United States
Tampa, Florida, United States
Pinehurst, North Carolina, United States
Catania, , Italy
San Juan, , Puerto Rico
Hawthorne, New York, United States
San Antonio, Texas, United States
Caba, , Argentina
Sherbrooke, Quebec, Canada
Jindrichuv Hradec, , Czechia
Prague, , Czechia
Prag, , Czechia
Bristol, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported