Comparative Relative Lung Bioavailability of HFA-Seretide via spacer devices in healthy volunteers - Lung Bioavailability of HFA-Seretide via spacers

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003627-20-GB

Enrollment

Registered

2008-12-16

Start date

2009-01-28

Completion date

Unknown

Last updated

2017-07-03

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: Seretide Evohaler Product Name: Seretide 250 Evohaler Pharmaceutical Form: Pressurised inhalation, suspension Pharmaceutical form of the placebo: Pressurised inhalation, suspension Route o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Volunteers 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. No respiratory disease 2. Smokers 3. Recent respiratory tract infection (2 months). 4. 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. 5. Any significant abnormal laboratory result as deemed by the investigators 6. Pregnancy, planned pregnancy or lactation 7. Known or suspected contra-indication to any of the IMP’s 8. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To establish whether, the systemic bioavailability of inhaled Seretide® HFA formulation is comparable via the pMDI, Volumatic®, Aerochamber™ Plus and Synchro-breathe devices;Secondary Objective: ;Primary end point(s): 1. The primary endpoint will be overnight urinary cortisol to creatinine ratio as a surrogate for the lung bioavailability of the fluticasone moiety. 2. The secondary endpoints will be change in serum potassium from baseline as a surrogate for systemic beta adrenoreceptor response of the salmeterol moiety; and early morning urinary cortisol to creatinine ratio as another surrogate of the lung bioavailability of the fluticasone moiety	—

Measure

Time frame

Main Objective: 1. To establish whether, the systemic bioavailability of inhaled Seretide® HFA formulation is comparable via the pMDI, Volumatic®, Aerochamber™ Plus and Synchro-breathe devices;Secondary Objective: ;Primary end point(s): 1. The primary endpoint will be overnight urinary cortisol to creatinine ratio as a surrogate for the lung bioavailability of the fluticasone moiety. 2. The secondary endpoints will be change in serum potassium from baseline as a surrogate for systemic beta adrenoreceptor response of the salmeterol moiety; and early morning urinary cortisol to creatinine ratio as another surrogate of the lung bioavailability of the fluticasone moiety

—

Countries

United Kingdom

Outcome results

None listed

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