WHO ICTRP trial
A double-blind, placebo controlled, multicentre, clinical trial to investigate…
EUCTR2015-002743-33-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2015-002743-33-GB |
|---|---|
| Public title | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) |
| Scientific title | A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)… |
| Primary sponsor | Zambon S.p.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Portugal;Greece;Spain;Israel;United Kingdom;Italy;Switzerland;France;Belgium;Australia;Germany;Netherlands;New Zealand |
| Conditions | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal… |
| Interventions | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Other descriptive name: Colistimethate Sodium Concentration… |
| Registration date | Dec 13, 2016 |
| Target size | 420 |
| Secondary IDs | Z7224L01 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: