WHO ICTRP trial
Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler…
EUCTR2021-003334-36-DE · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2021-003334-36-DE |
|---|---|
| Public title | Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma |
| Scientific title | A Randomized, Double-Blind, Parallel Group, Multicenter 12 Week Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Metered Dose Inhaler Relative to Budesonide Metered Dose Inhaler in Participants with Inadequately Controlled Asthma (LITHOS) - LITHOS |
| Primary sponsor | AstraZeneca AB |
| 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): yes Therapeutic use (Phase IV): no |
| Countries | United States;Czechia;Canada;Spain;Germany |
| Conditions | Inadequately Controlled Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract… |
| Interventions | Product Name: Budesonide and formoterol fumarate pressurised inhalation suspension, desiccated flow path Product Code: PT009, BFF MDI DFP 80 Pharmaceutical Form: Pressurised inhalation, suspension INN or Proposed INN: Budesonide CAS Number… |
| Registration date | Nov 17, 2022 |
| Target size | 340 |
| Secondary IDs | D5982C00005 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: