COMPARATIVE STUDY OF THE SYSTEMIC BIOACTIVITY OF HFA FLUTICASONE PROPIONATE VIA ANTI-STATIC SPACER DEVICES

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Flixotide 250 microgram Evohaler Product Name: Flixotide 250microgram Evohaler Pharmaceutical Form: Pressurised inhalation, suspension Pharmaceutical form of the placebo: Pressurised inhalation, suspension Route of administration of the placebo: Inhalation use CONDITION: Bronchial Asthma PRIMARY OUTCOME: Main Objective: To establish whether, the systemic bioactivity of inhaled fluticasone propionate HFA formulation is comparable via the pMDI, Aerochamber® Max, Zerostat®, and Nebuchamber® devices. Primary end point(s): 1. The primary endpoint will be overnight urinary cortisol to creatinine ratio. Secondary Objective: INCLUSION CRITERIA: 1. Mild to moderate stable asthmatics on =800µg BDP or equivalent 2. Male or female 18‐65 3. Informed Consent 4. Ability to comply with the requirements of the protocol Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 930ec13e1bd3887ea27556378a47861834c72dd0
First added on: Aug 21, 2024