Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

Brian J Lipworth

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Seretide 250(8puffs) via Evohaler actuator; Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer; Drug: Seretide 250/placebo via Synchro-Breathe; Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer

Study type: Interventional

Funder types: Other

Identifiers

NCT01194700

NAI008

2007-003627-20 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the effect of plastic spacers and breath actuated spacers on respirable drug delivery of combination steroid inhaler (Seretide/Advair) and whether electrostatic charge within plastic spacers has a clinically relevant impact on the inhaled steroid delivery.

Full description

Conventional plastic spacers are bulky and can be influenced by electrostatic charge, which can reduce respirable dose delivery especially when used brand new "out of the box". Breath actuated integrated vortex spacer (Synchro-Breathe) is a compact palm sized antistatic device with a vortex chamber which is designed to be more patient friendly and free from the effects of electrostatic charge. The systemic bioavailability from the lung of inhaled fluticasone and salmeterol is dependent on respirable dose delivery, and hence the performance of inhaler devices can be quantified by measuring the degree of adrenal suppression and fall in serum potassium(K) as surrogates for delivered lung dose. This study attempts to compares the systemic bioavailability from the lung in real life conditions for Fluticasone/Salmeterol combination (measured in terms of relative adrenal suppression and fall in serum K) via the breath actuated Synchro-Breathe device, pMDI( Seretide Evohaler), and Aerochamber Plus & Volumatic spacer used brand new "out of the box" in healthy volunteers.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy Volunteers
2. Male or female 18-65
3. Informed Consent
4. Ability to comply with the requirements of the protocol

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

19 participants in 4 patient groups

Evohaler

Experimental group

Treatment:

Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer

Drug: Seretide 250/placebo via Synchro-Breathe

Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Drug: Seretide 250(8puffs) via Evohaler actuator

Volumatic spacer

Experimental group

Treatment:

Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer

Drug: Seretide 250/placebo via Synchro-Breathe

Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Drug: Seretide 250(8puffs) via Evohaler actuator

Aerochamber Plus

Experimental group

Treatment:

Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer

Drug: Seretide 250/placebo via Synchro-Breathe

Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Drug: Seretide 250(8puffs) via Evohaler actuator

Synchro-Breathe

Experimental group

Treatment:

Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer

Drug: Seretide 250/placebo via Synchro-Breathe

Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Drug: Seretide 250(8puffs) via Evohaler actuator