WHO ICTRP trial
Study to evaluate the efficacy and safety of glycopyrronium or indacaterol…
EUCTR2013-003127-11-CZ · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2013-003127-11-CZ |
|---|---|
| Public title | Study to evaluate the efficacy and safety of glycopyrronium or indacaterol maleate and glycopyrronium bromide fixed - dose combination regarding symptoms and health status in patients with moderate COPD switching from treatment with any standard COPD regimen |
| Scientific title | A prospective, multicenter, 12-week, randomized open-label study to evaluate the efficacy and safety of glycopyrronium (50 micrograms o.d.) or indacaterol maleate and glycopyrronium bromide fixed-dose combination (110/50 micrograms o.d.) regarding symptoms and health status in patients with moderate… |
| Primary sponsor | Novartis Pharma Services AG |
| 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): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes |
| Countries | Portugal;Estonia;Slovakia;Slovenia;Greece;Spain;Ireland;Lithuania;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech… |
| Conditions | Chronic obstructive pulmonary disease (COPD) MedDRA version: 19.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] |
| Interventions | Trade Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsule Product Name: Seebri Breezhaler 44 micrograms inhalation powder, hard capsule Product Code: NVA237 Pharmaceutical Form: Inhalation powder, hard capsule INN or… |
| Registration date | Jan 20, 2014 |
| Target size | 4470 |
| Secondary IDs | CQVA149A3401 |
| 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: