The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis
ConditionBronchiectasis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorBoehringer Ingelheim
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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. 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.
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
BI 1291583
DrugBI 1291583
Placebo matching BI 1291583
DrugPlacebo matching BI 1291583
Treatment groups
1,755 Participants
are divided into 2 treatment groupsGroup A: Treatment armExperimental treatment 1 intervention
Group B: Placebo armPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Annualised rate of adjudicated pulmonary exacerbations (number of events per person year) up to Week 76
Time frame
up to 76 weeksSecondary outcomes
1
Time to first adjudicated pulmonary exacerbation up to Week 76
Time frame
up to 76 weeks2
Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOL-B) respiratory symptoms domain score at Week 52 (participants ≥ 16 years)
The QOL-B is a patient reported outcome (PRO) measure assessing symptoms, functioning and health-related quality of life of patients with bronchiectasis. It consists of 37 items covering the following domains: respiratory symptoms, physical functioning, vitality, role functioning, health perception, emotional functioning, social functioning, and treatment burden. All items are rated on a 4-point response scale ranging from 'a lot' to 'not at all' with the recall period 'the previous week'. Domain scores are generated ranging from 0 to 100, with higher scores indicating less symptom burden, better functioning, and higher health-related quality of life respectively.
Time frame
at baseline, at week 523
Absolute change from baseline in post-bronchodilator Forced Expiratory Volume in the first second (FEV1) %pred at Week 52
Time frame
at baseline, at week 524
Absolute change from baseline in post-bronchodilator Forced Vital Capacity (FVC) %pred at Week 52
Time frame
at baseline, at week 52Sponsors and contacts
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Source ClinicalTrials.gov