WHO ICTRP trial
A study to evaluate the effects of indacaterol maleate as a new formulation in…
EUCTR2011-001824-39-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2011-001824-39-GB |
|---|---|
| Public title | A study to evaluate the effects of indacaterol maleate as a new formulation in the EPIC test fixture. |
| Scientific title | A randomized, double-blind, double-dummy, placebo-controlled, 3-period crossover study to evaluate the pharmacodynamics, pharmacokinetics, safety and tolerability of orally inhaled indacaterol administered via the EPIC test fixture and the Concept1 device in adult patients with persistent asthma. |
| 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United Kingdom |
| Conditions | Persistent Asthma MedDRA version: 14.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1 Level… |
| Interventions | Product Name: QAB149 75mcg Product Code: QAB149 Pharmaceutical Form: Inhalation powder, hard capsule Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Product Name… |
| Registration date | Nov 4, 2013 |
| Target size | 42 |
| Secondary IDs | CMID001A2201 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
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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: