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The AIRTIVITY TM Study: A study to find out whether BI 1291583 helps people with bronchiectasis
EU CTIS ID: 2024-518589-29-00
What this study is testing
To demonstrate superiority of BI 1291583 compared to placebo on the primary endpoint, the annualised rate of adjudicated pulmonary exacerbations in participants with bronchiectasis
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Male or female participants. WOCBP 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 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 and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
- Age of participants when signing the informed consent/assent ≥12 years. a. Adolescents need to weigh at least 35 kg at Visit 1.
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist. 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.
- Adult participants should be able to produce sputum for P. aeruginosa assessment during the screening period.
- 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 >40 at screening Visit 1 (adults only) c. at least 1 exacerbation and high symptom burden according to the investigator’s judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.
You likely can't join if
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- eGFR according to CKD-EPI formula (adults) or CKiD-U25 (adolescents) <30 mL/min at Visit 1.
- Previous treatment with a DPP1 (CatC) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed).
- Further exclusion criteria apply.
- Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
See the full eligibility criteria
Who can join
- Male or female participants. WOCBP 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 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 and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation.
- Age of participants when signing the informed consent/assent ≥12 years. a. Adolescents need to weigh at least 35 kg at Visit 1.
- Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist. 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.
- Adult participants should be able to produce sputum for P. aeruginosa assessment during the screening period.
- 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 >40 at screening Visit 1 (adults only) c. at least 1 exacerbation and high symptom burden according to the investigator’s judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on CFTR-MT, at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.
What rules you out
- Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation.
- eGFR according to CKD-EPI formula (adults) or CKiD-U25 (adolescents) <30 mL/min at Visit 1.
- Previous treatment with a DPP1 (CatC) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed).
- Further exclusion criteria apply.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Egypt
- Chile
- India
- United Kingdom
- Israel
- Hong Kong
- Kazakhstan
- New Zealand
- Australia
- United States
- Singapore
- Argentina
- Korea, Republic of
- Switzerland
- Philippines
- Japan
- Vietnam
- Mexico
- Serbia
- Turkey
+ 7 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Egypt; Chile; India; United Kingdom; Israel; Hong Kong and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.