WHO ICTRP trial
A randomised, double-blind, placebo-controlled, parallel group, dose-finding…
NL-OMON53709 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting
Key facts
| Trial ID | NL-OMON53709 |
|---|---|
| Public title | A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf*) |
| Scientific title | A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf*) - CatC inhibitor Phase II in bronchiectasis (1397-0012) / (Airleaf*) |
| Primary sponsor | Boehringer Ingelheim |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Recruitment status | Recruiting |
| Study type | Interventional |
| Phase | 2 |
| Countries | Australia;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea (the Republic of);Latvia;Mexico;Netherlands;Poland;Portugal;Spain;Turkey;United Kingdom;United… |
| Conditions | bronchiectasis dilatation and inflammation of the bronchi;10006436;bronchiectasis;dilatation and inflammation of the bronchi |
| Interventions | 24 to 48 weeks of treatment with BI 1291538 (orally, qd). - Placebo qd (n = 80) - BI 1291583 1 mg qd (n = 40) - BI 1291583 2.5 mg qd (n = 40) - BI 1291583 5 mg qd (n = 80) Also refer to protocol section 4.1. ;BI 1291583;bronchiectasis;CatC… |
| Registration date | Jun 2, 2023 |
| Target size | 7 |
| Secondary IDs | 2021-003304-41;NCT05238675;NL79730.100.21 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: