Testing BI 1291583 against a placebo for bronchiectasis
Official title: The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
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)
- Phase 3
- 2 groups
- Sites in Québec, Calgary and 8 more cities
- Recruiting
Interventions
- Medication
BI 1291583
BI 1291583
- Medication
Placebo matching BI 1291583
Placebo matching BI 1291583
Canadian Sites (10)
10 of 10 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia
- Recruiting
Cardio 1 Medical Clinic
Winnipeg, Manitoba
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
BLC Clinical Research
Burlington, Ontario
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
- Recruiting
Diex Recherche (Sherbrooke Est)
Sherbrooke, Quebec
- Recruiting
Diex Recherche (Trois-Rivieres)
Trois-Rivières, Quebec
- Recruiting
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Signed and dated written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → 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.
- +\-- 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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 ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more →. Historical scans must not be older than five years.
- +Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period.
- +History of documented pulmonary exacerbations (assessed and recorded by the investigator) 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 (adults only)
- +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 Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT.
- +Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth controlControl groupThe group a new treatment is measured against.Read more → 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. A list of contraception methods meeting these criteria is provided in the participant information.
Exclusion
- −Allergic bronchopulmonary aspergillosis being treated or requiring treatment.
- −Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment
- −Any findings in the medical examination and/or laboratory value assessed at Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more → 1 or during screening period, that in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → 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.
- −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 (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<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 placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
- −Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives BI 1291583.
Registry label: A: Treatment arm
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo matching BI 1291583.
Registry label: B: Placebo arm
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 12 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,755 people.
The study is currently expected to finish around December 2027.
The main measurement is taken over: up to 76 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76 — measured over up to 76 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06872892 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About BI 1291583Drug
BI 1291583
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Placebo matching BI 1291583Drug
Placebo matching BI 1291583
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 12 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 12 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: up to 76 weeks.
The study as a whole is currently expected to finish around 2027-12-20.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,755 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Québec, Canada; Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Burlington, Ontario, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.
Other Sites (11)
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
HealthPartners Specialty Center 401 Building
Saint Paul, Minnesota, United States
New York Medical College - Hawthorne
Hawthorne, New York, United States
Northwell Health
New Hyde Park, New York, United States
New York University Langone Medical Center
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
Providence Medical Research Center
Spokane, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.