COMPARATIVE STUDY OF THE SYSTEMIC BIOACTIVITY OF HFA FLUTICASONE PROPIONATE VIA ANTI-STATIC SPACER DEVICES - Systemic Bioactivity of Fluticsone via antistatic spacer devices Ver1

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005557-22-GB

Enrollment

Registered

2006-01-06

Start date

2006-02-17

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial Asthma

Interventions

Trade Name: Flixotide 250 microgram Evohaler Product Name: Flixotide 250microgram Evohaler Pharmaceutical Form: Pressurised inhalation, suspension Pharmaceutical form of the placebo: Pressurised inhal

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Severe asthmatics as defined by an FEV1= 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms. 2. The use of oral corticosteroids within the last 3 months. 3. Recent respiratory tract infection (2 months). 4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis. 5. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA,that may endanger the health or safety of the participant, or jeopardise the protocol. 6. Any significant abnormal laboratory result as deemed by the investigators 7. Pregnancy, planned pregnancy or lactation 8. Known or suspected contra-indication to any of the IMP’s 9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

Design outcomes

Primary

Measure	Time frame
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.;Secondary Objective: ;Primary end point(s): 1. The primary endpoint will be overnight urinary cortisol to creatinine ratio.	—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026