Clinical Trials List
Protocol Number1397-0014
Active
2025-06-16 - 2029-09-30
Phase III
Recruiting6
ICD-10J47.9
Bronchiectasis, uncomplicated
ICD-9494.0
Bronchiectasis without acute exacerbation
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 AIRTIVITYR Study)
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Trial Applicant
Boehringer Ingelheim
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Sponsor
Boehringer Ingelheim Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳友木 Division of Thoracic Medicine
- 蔡孟耘 Division of Thoracic Medicine
- 黃國棟 Division of Thoracic Medicine
- Chia-Cheng Tseng Division of Thoracic Medicine
- 陳永哲 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 李孟叡 Division of General Internal Medicine
- Jung-Yien Chien Division of General Internal Medicine
- 黃俊凱 Division of General Internal Medicine
- 郭耀文 Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Jen-Yu Hung
Co-Principal Investigator
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- 郭家佑 Division of Thoracic Medicine
- 李岱晃 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Bronchiectasis
Objectives
This study aims to evaluate the efficacy, safety, and tolerability of BI 1291583 2.5 mg once daily (q.d.) compared with placebo in participants with bronchiectasis, regardless of the underlying etiology. The study will assess the ability of BI 1291583 2.5 mg to reduce the frequency of pulmonary exacerbations in patients with bronchiectasis over a treatment period of at least 52 weeks and up to 76 weeks, as well as to evaluate its overall benefit–risk profile.
Test Drug
BI 1291583 or matching placebo
Active Ingredient
BI 1291583 or matching placebo
Dosage Form
116
Dosage
2.5 mg
Endpoints
Annualized rate of pulmonary exacerbations (number of events per patient-year) up to Week 76.
Inclution Criteria
Inclusion Criteria (English Translation)
Male or female participants. Women of childbearing potential (WOCBP)* must be willing and able to use a highly effective contraceptive method per ICH M3(R2)—i.e., a method with a failure rate <1% per year when used consistently and correctly—and simultaneously use a barrier method. A list of acceptable methods is provided in the participant information.
Signed and dated written informed consent obtained prior to entry into the study, in accordance with GCP and applicable local laws.
Age ≥18 years at the time of consent (or at least the legal age of consent in countries where it exceeds 18 years).
Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production, recurrent respiratory infections) and diagnosis confirmed by CT scan by the investigator. Participants without prior CT imaging will undergo a chest CT during screening. Prior scans must be no older than 5 years.
Able to produce sputum for screening (see Section A).
Documented history of pulmonary exacerbation(s) requiring antibiotic therapy. Within the 12 months prior to Visit 1, participants must have:
a) At least 2 exacerbations, or
b) At least 1 exacerbation and an SGRQ Symptoms score >40 at Screening Visit 1.
For participants on stable oral or inhaled antibiotics as long-term therapy for bronchiectasis, and for those on CFTR modulator therapy (CFTR-MT), at least one exacerbation must have occurred since the start of stable antibiotic therapy or CFTR-MT.
* Definition of WOCBP: Females from menarche until postmenopause, unless permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Tubal ligation is not considered a method of permanent sterilization. Postmenopausal status is defined as 12 months of amenorrhea without other medical cause; for women not using hormonal contraception or hormone replacement therapy, postmenopause may be confirmed by elevated FSH within the postmenopausal range at the investigator’s discretion (gynecologic consultation may be sought), per Clinical Trial Facilitation Group guidance.
Male or female participants. Women of childbearing potential (WOCBP)* must be willing and able to use a highly effective contraceptive method per ICH M3(R2)—i.e., a method with a failure rate <1% per year when used consistently and correctly—and simultaneously use a barrier method. A list of acceptable methods is provided in the participant information.
Signed and dated written informed consent obtained prior to entry into the study, in accordance with GCP and applicable local laws.
Age ≥18 years at the time of consent (or at least the legal age of consent in countries where it exceeds 18 years).
Clinical history consistent with bronchiectasis (e.g., cough, chronic sputum production, recurrent respiratory infections) and diagnosis confirmed by CT scan by the investigator. Participants without prior CT imaging will undergo a chest CT during screening. Prior scans must be no older than 5 years.
Able to produce sputum for screening (see Section A).
Documented history of pulmonary exacerbation(s) requiring antibiotic therapy. Within the 12 months prior to Visit 1, participants must have:
a) At least 2 exacerbations, or
b) At least 1 exacerbation and an SGRQ Symptoms score >40 at Screening Visit 1.
For participants on stable oral or inhaled antibiotics as long-term therapy for bronchiectasis, and for those on CFTR modulator therapy (CFTR-MT), at least one exacerbation must have occurred since the start of stable antibiotic therapy or CFTR-MT.
* Definition of WOCBP: Females from menarche until postmenopause, unless permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. Tubal ligation is not considered a method of permanent sterilization. Postmenopausal status is defined as 12 months of amenorrhea without other medical cause; for women not using hormonal contraception or hormone replacement therapy, postmenopause may be confirmed by elevated FSH within the postmenopausal range at the investigator’s discretion (gynecologic consultation may be sought), per Clinical Trial Facilitation Group guidance.
Exclusion Criteria
Exclusion Criteria (English Translation)
Laboratory and medical examinations
Evidence or history of moderate or severe hepatic disease (Child–Pugh class B or C hepatic impairment).
Absolute neutrophil count (ANC) < 1,000/mm³ (i.e., <1,000 cells/µL or <10⁹ cells/L) at Visit 1.
Estimated glomerular filtration rate (eGFR) < 30 mL/min at Visit 1, calculated by the CKD-EPI equation.
Total IgG < 5 g/L at Visit 1.
Any finding on medical examination and/or laboratory testing at Screening Visit 1 or during screening that, in the investigator’s judgment, may place the participant at risk from study participation. (Visit 1 lab parameters must meet the thresholds listed above. Visit 2 lab results will only be available after randomization. If Visit 2 results no longer meet inclusion criteria, the investigator must determine whether continued participation is reasonable; the rationale must be documented.)
Relevant chronic or acute infections, including but not limited to HIV and viral hepatitis. Corresponding laboratory tests will be performed during screening.
Concomitant diagnoses and treatments
7. Any new-onset or newly diagnosed primary or secondary immunodeficiency within 1 year prior to randomization.
a. Participants diagnosed with primary or secondary immunodeficiency (e.g., common variable immunodeficiency [CVID], hypogammaglobulinemia) >1 year prior to randomization may be included if the condition is judged stable within the year prior (i.e., no severe or life-threatening infections and either on appropriate maintenance therapy with stable control or, per current guidelines, no therapy required within the past year).
b. Eligible immunodeficient participants:
• Must remain under standard-of-care monitoring and treatment by a specialist aware of study participation and receive standard-of-care management of intercurrent infections.
• Must have completed age-appropriate vaccinations per local guidelines (e.g., CDC adult schedule) prior to Visit 1, and be willing to maintain appropriate vaccination status during the study.
8. Allergic bronchopulmonary aspergillosis that is being treated or requires treatment.
9. Palmoplantar keratoderma, keratoderma climactericum, or hyperkeratosis, unless clinically stable for ≥3 months prior to randomization.
10. Tuberculosis or nontuberculous mycobacterial (NTM) infection that is being treated or requires treatment per local guidelines (laboratory testing, e.g., QuantiFERON-TB Gold, may be performed at the investigator’s discretion or per local requirements).
11. Any clinically significant acute respiratory infection or ongoing pulmonary exacerbation at the screening visit(s), unless deemed resolved by the investigator prior to Visit 2.
12. Any meaningful pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immune, endocrine, or other disorder that, in the investigator’s judgment, may place the participant at risk from study participation.
13. Any evidence of primary lateral sclerosis (PLS).
14. Participants who must or wish to continue taking restricted medications or any drugs considered likely to interfere with safe conduct of the study.
Other / general conditions
15. Major surgery within 6 weeks prior to randomization (as judged by the investigator), or planned major surgery during the study.
16. Any active or suspected malignancy within 5 years prior to screening, or a history of malignancy, except adequately treated non-melanoma skin carcinoma in situ or cervical carcinoma in situ.
17. Anticipated non-compliance with the protocol or inability to complete the study as scheduled (e.g., chronic alcohol or drug abuse, or any condition rendering the participant unreliable in the investigator’s opinion).
18. Clinically significant hemoptysis (≥300 mL and/or requiring transfusion) within 4 weeks prior to Screening Visit 1 (and during screening).
19. Current smoker, or cessation within 3 months prior to screening, or unwillingness to remain abstinent from smoking during the study.
20. Current enrollment in another investigational device or drug study; or completion of participation in another investigational device/drug study or receipt of another investigational treatment less than 30 days or 5 half-lives (whichever is longer) prior to Visit 2.
21. Prior treatment with a dipeptidyl peptidase-1 (DPP1; cathepsin C [CatC]) inhibitor. (Note: Participants randomized to placebo only in a DPP1 [CatC] inhibitor trial may be allowed.)
22. Pregnant, breastfeeding, or planning to become pregnant during the study.
23. Contraindication to this class of study medication, including known hypersensitivity to the drug or its excipients.
24. Participants who, in the investigator’s judgment, are likely to require referral for transplantation within the next 12 months.
Laboratory and medical examinations
Evidence or history of moderate or severe hepatic disease (Child–Pugh class B or C hepatic impairment).
Absolute neutrophil count (ANC) < 1,000/mm³ (i.e., <1,000 cells/µL or <10⁹ cells/L) at Visit 1.
Estimated glomerular filtration rate (eGFR) < 30 mL/min at Visit 1, calculated by the CKD-EPI equation.
Total IgG < 5 g/L at Visit 1.
Any finding on medical examination and/or laboratory testing at Screening Visit 1 or during screening that, in the investigator’s judgment, may place the participant at risk from study participation. (Visit 1 lab parameters must meet the thresholds listed above. Visit 2 lab results will only be available after randomization. If Visit 2 results no longer meet inclusion criteria, the investigator must determine whether continued participation is reasonable; the rationale must be documented.)
Relevant chronic or acute infections, including but not limited to HIV and viral hepatitis. Corresponding laboratory tests will be performed during screening.
Concomitant diagnoses and treatments
7. Any new-onset or newly diagnosed primary or secondary immunodeficiency within 1 year prior to randomization.
a. Participants diagnosed with primary or secondary immunodeficiency (e.g., common variable immunodeficiency [CVID], hypogammaglobulinemia) >1 year prior to randomization may be included if the condition is judged stable within the year prior (i.e., no severe or life-threatening infections and either on appropriate maintenance therapy with stable control or, per current guidelines, no therapy required within the past year).
b. Eligible immunodeficient participants:
• Must remain under standard-of-care monitoring and treatment by a specialist aware of study participation and receive standard-of-care management of intercurrent infections.
• Must have completed age-appropriate vaccinations per local guidelines (e.g., CDC adult schedule) prior to Visit 1, and be willing to maintain appropriate vaccination status during the study.
8. Allergic bronchopulmonary aspergillosis that is being treated or requires treatment.
9. Palmoplantar keratoderma, keratoderma climactericum, or hyperkeratosis, unless clinically stable for ≥3 months prior to randomization.
10. Tuberculosis or nontuberculous mycobacterial (NTM) infection that is being treated or requires treatment per local guidelines (laboratory testing, e.g., QuantiFERON-TB Gold, may be performed at the investigator’s discretion or per local requirements).
11. Any clinically significant acute respiratory infection or ongoing pulmonary exacerbation at the screening visit(s), unless deemed resolved by the investigator prior to Visit 2.
12. Any meaningful pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immune, endocrine, or other disorder that, in the investigator’s judgment, may place the participant at risk from study participation.
13. Any evidence of primary lateral sclerosis (PLS).
14. Participants who must or wish to continue taking restricted medications or any drugs considered likely to interfere with safe conduct of the study.
Other / general conditions
15. Major surgery within 6 weeks prior to randomization (as judged by the investigator), or planned major surgery during the study.
16. Any active or suspected malignancy within 5 years prior to screening, or a history of malignancy, except adequately treated non-melanoma skin carcinoma in situ or cervical carcinoma in situ.
17. Anticipated non-compliance with the protocol or inability to complete the study as scheduled (e.g., chronic alcohol or drug abuse, or any condition rendering the participant unreliable in the investigator’s opinion).
18. Clinically significant hemoptysis (≥300 mL and/or requiring transfusion) within 4 weeks prior to Screening Visit 1 (and during screening).
19. Current smoker, or cessation within 3 months prior to screening, or unwillingness to remain abstinent from smoking during the study.
20. Current enrollment in another investigational device or drug study; or completion of participation in another investigational device/drug study or receipt of another investigational treatment less than 30 days or 5 half-lives (whichever is longer) prior to Visit 2.
21. Prior treatment with a dipeptidyl peptidase-1 (DPP1; cathepsin C [CatC]) inhibitor. (Note: Participants randomized to placebo only in a DPP1 [CatC] inhibitor trial may be allowed.)
22. Pregnant, breastfeeding, or planning to become pregnant during the study.
23. Contraindication to this class of study medication, including known hypersensitivity to the drug or its excipients.
24. Participants who, in the investigator’s judgment, are likely to require referral for transplantation within the next 12 months.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
1755 participants
