A two-way crossover, sequential-dose, double-blinded, double-dummy, multiple dose, pharmacodynamic, comparative study of fluticasone propionate, 500 µg and 1000 µg twice daily delivered via pressurized metered dose inhaler versus Flixotide®, 500 µg and 1000 µg twice daily delivered via pressurized metered dose inhaler in patients with mild stable asthma - TITAN

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-006078-84-GB

Enrollment

Registered

2007-06-26

Start date

2008-07-24

Completion date

Unknown

Last updated

2020-07-27

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

Conditions

Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Trade Name: Flixotide 125 micrograms Evohaler Pharmaceutical Form: Pressurised inhalation, suspension INN or Proposed INN: fluticasone propionate CAS Number: 80474-14-2 Concentration unit: µg microgra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women aged 18-65 years; mild stable asthma, controlled with a low-dose 'preventer' steroid inhaler; forced expiratory volume in 1 second (FEV1) at least 80% of predicted; in good general health; able to communicate with study personnel; reliable, willing, and likely to comply with the protocol; able to use the study inhalers correctly; consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS). 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: We exclude participants who meet the following criteria: severe asthma; hospital treatment for asthma in the 6 months before screening; needed antibiotics for a chest infection or a bad flare-up of asthma in the 6 weeks before screening; abuse of alcohol or drugs; recent use of over-the-counter medicines or prescription medicines (other than a steroid 'preventer' inhaler, a short-acting 'reliever' inhaler, or low-dose hormonal contraceptives); history of any serious problem with the lungs, other than asthma (such as tuberculosis); any clinically significant disease; serious reaction to any medicine, particularly fluticasone propionate or similar drugs; pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol; have donated blood, or taken part in another study, within the past 3 months; heavy smokers.

Design outcomes

Primary

Measure	Time frame
Main Objective: To find out if the study medicine (a generic formulation of fluticasone propionate) is as safe as Flixotide, by measuring their effects on blood and urine levels of cortisol (a steroid produced by the body).;Secondary Objective: To compare the side effects and efficacy of Flixotide and the study medicine.;Primary end point(s): Change from baseline in the area under the plasma cortisol-time curve (AUC0-24 h).	—

Measure

Time frame

Main Objective: To find out if the study medicine (a generic formulation of fluticasone propionate) is as safe as Flixotide, by measuring their effects on blood and urine levels of cortisol (a steroid produced by the body).;Secondary Objective: To compare the side effects and efficacy of Flixotide and the study medicine.;Primary end point(s): Change from baseline in the area under the plasma cortisol-time curve (AUC0-24 h).

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Countries

United Kingdom

Outcome results

None listed

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