drugset / Trial / NCT01113034
A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The primary objective is to evaluate whether DAS181 is safe in subjects with well-controlled asthma or bronchiectasis.
Timeline
- Start
- 2010-07
- Primary completion
- 2011-08-22
- Completion
- 2011-08-22
Publications
- Davey EL, Colombo RE, Fiorentino C, Fahle G, Davey RT Jr, Olivier KN, Kovacs JA. Pneumocystis colonization in asthmatic patients not receiving oral corticosteroid therapy. J Investig Med. 2017 Apr;65(4):800-802. doi: 10.1136/jim-2016-000381. Epub 2017 Feb 13.
- Colombo RE, Fiorentino C, Dodd LE, Hunsberger S, Haney C, Barrett K, Nabha L, Davey RT Jr, Olivier KN. A phase 1 randomized, double-blind, placebo-controlled, crossover trial of DAS181 (Fludase(R)) in adult subjects with well-controlled asthma. BMC Infect Dis. 2016 Feb 1;16:54. doi: 10.1186/s12879-016-1358-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | DAS181 | Protein / enzyme biologic | 10 mg | Inhaled |