Informations générales (source: ClinicalTrials.gov)
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study (ASPEN)
Interventional
Phase 3
Insmed Incorporated (Voir sur ClinicalTrials)
décembre 2020
mars 2024
19 octobre 2024
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and
25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week
treatment period.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Bernard MAITRE | 16/04/2024 14:11:35 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| FRA002 - 67091 - Strasbourg - Bas-Rhin - France | Contact (sur clinicalTrials) | ||||
| FRA003 - 44093 - Nantes - France | Contact (sur clinicalTrials) | ||||
| FRA004 - 80054 - Amiens cedex 1 - France | Contact (sur clinicalTrials) | ||||
| FRA005 - 34295 - Montpellier - Hérault - France | Contact (sur clinicalTrials) | ||||
| FRA006 - 31400 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| FRA009 - 6002 - Nice - France | Contact (sur clinicalTrials) | ||||
| FRA010 - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| FRA011 - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Provide their signed study informed consent to participate.
a. Adolescent participants must have signed study assent form to participate, and
the adolescent's parent or legal guardian must have provided signed informed consent
for the adolescent to participate.
2. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough,
chronic sputum production and/or recurrent respiratory infections) that is confirmed
by chest computerized tomography (CT) scan.
3. At least 2 PEs defined by need for antibiotic prescription by a physician for the
signs and symptoms of respiratory infections in the past 12 months before the
Screening Visit.
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in
the prior 12 months.
4. Women must be postmenopausal (defined as no menses for 12 months without an
alternative medical cause), surgically sterile, or using highly effective
contraception (ie, methods that can achieve a failure rate <1% per year when used
consistently and correctly) from Day 1 to at least 90 days after the last dose.
5. Male participants with female partners of childbearing potential must be using
effective contraception from Day 1 to at least 90 days after the last dose.
6. Male participants with pregnant or non-pregnant women of child-bearing potential
partners must use condoms to avoid potential exposure to the embryo/fetus.
1. Provide their signed study informed consent to participate.
a. Adolescent participants must have signed study assent form to participate, and
the adolescent's parent or legal guardian must have provided signed informed consent
for the adolescent to participate.
2. Clinical history consistent with non-cystic fibrosis bronchiectasis (NCFBE) (cough,
chronic sputum production and/or recurrent respiratory infections) that is confirmed
by chest computerized tomography (CT) scan.
3. At least 2 PEs defined by need for antibiotic prescription by a physician for the
signs and symptoms of respiratory infections in the past 12 months before the
Screening Visit.
a. Adolescent participants are required to have at least 1 pulmonary exacerbation in
the prior 12 months.
4. Women must be postmenopausal (defined as no menses for 12 months without an
alternative medical cause), surgically sterile, or using highly effective
contraception (ie, methods that can achieve a failure rate <1% per year when used
consistently and correctly) from Day 1 to at least 90 days after the last dose.
5. Male participants with female partners of childbearing potential must be using
effective contraception from Day 1 to at least 90 days after the last dose.
6. Male participants with pregnant or non-pregnant women of child-bearing potential
partners must use condoms to avoid potential exposure to the embryo/fetus.
1. A primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma as
judged by the Investigator.
2. Bronchiectasis due to cystic fibrosis.
3. Current smokers as defined per Centers for Disease Control (CDC).
4. Known or suspected immunodeficiency disorder, including history of invasive
opportunistic infections.
5. Known history of human immunodeficiency virus (HIV) infection.
6. Currently being treated for nontuberculous mycobacteria (NTM) lung infection,
allergic bronchopulmonary aspergillosis, or tuberculosis (TB).
7. Active and current symptomatic infection by 2019 corona virus disease (COVID-19).
8. Inability to follow the procedures of the study (eg, due to language problems or
psychological disorders).
9. Receiving medications or therapy that are prohibited as concomitant medications.
10. Previously participated in a clinical trial for brensocatib.
11. Received any live attenuated vaccine within 4 weeks prior to the first
administration of brensocatib.
12. Suffering an exacerbation 4 weeks before Screening or during the Screening period.
13. Adult participants only: Have compliance issues with completion of electronic diary
entries during the Screening Period and in the opinion of the Investigator,
compliance is unlikely to improve during the study.
14. Participated in any other interventional clinical studies within 3 months before
Screening Visit.
15. History of alcohol or drug abuse within 6 months prior to the Screening Visit.
16. Is the Investigator or any Sub-Investigator, research assistant, pharmacist, study
coordinator, other staff or relative thereof directly involved in the conduct of the
study.
17. Known history of hypersensitivity to brensocatib or any of its excipients.