WHO ICTRP trial
A clinical study to evaluate the efficacy of a drug (CHF 5993) comparing the…
EUCTR2017-004405-41-HU · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2017-004405-41-HU |
|---|---|
| Public title | A clinical study to evaluate the efficacy of a drug (CHF 5993) comparing the results obtained with two different pharmaceutical forms and the effects produced by another drug (CHF 1535), in patients with chronic obstructive pulmonary disease |
| Scientific title | A phase II, multicentre, randomised, double-blind, double-dummy, active-controlled, 3-way cross-over study to evaluate the efficacy of CHF 5993 administered via Dry Powder Inhaler (DPI) versus CHF 5993 via pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in patients with chronic obstructive… |
| Primary sponsor | Chiesi Farmaceutici S.p.A. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Czech Republic;Hungary;Poland;Bulgaria;Germany |
| Conditions | chronic obstructive pulmonary disease (COPD) MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] |
| Interventions | Product Name: CHF 5993 DPI NEXThaler® Pharmaceutical Form: Inhalation powder INN or Proposed INN: BECLOMETASONE DIPROPIONATE CAS Number: 5534-09-8 Current Sponsor code: CHF 718 Concentration unit: µg microgram(s) Concentration type: equal… |
| Registration date | Jun 3, 2018 |
| Target size | 506 |
| Secondary IDs | CLI-05993BA1-02;2017-004405-41-DE |
| Registry page | clinicaltrialsregister.eu |
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: