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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Evohaler

Group Type EXPERIMENTAL

Seretide 250(8puffs) via Evohaler actuator

Intervention Type DRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Seretide 250 (8 puffs)/placebo via Volumatic spacer

Intervention Type DRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Intervention Type DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Seretide 250/placebo via Synchro-Breathe

Intervention Type DRUG

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Volumatic spacer

Group Type EXPERIMENTAL

Seretide 250(8puffs) via Evohaler actuator

Intervention Type DRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Seretide 250 (8 puffs)/placebo via Volumatic spacer

Intervention Type DRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Intervention Type DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Seretide 250/placebo via Synchro-Breathe

Intervention Type DRUG

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Aerochamber Plus

Group Type EXPERIMENTAL

Seretide 250(8puffs) via Evohaler actuator

Intervention Type DRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Seretide 250 (8 puffs)/placebo via Volumatic spacer

Intervention Type DRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Intervention Type DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Seretide 250/placebo via Synchro-Breathe

Intervention Type DRUG

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Synchro-Breathe

Group Type EXPERIMENTAL

Seretide 250(8puffs) via Evohaler actuator

Intervention Type DRUG

8 puffs of Seretide250/Placebo via Evohaler actuator

Seretide 250 (8 puffs)/placebo via Volumatic spacer

Intervention Type DRUG

8 puffs of Seretide 250/placebo via volumatic spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Intervention Type DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus

Seretide 250/placebo via Synchro-Breathe

Intervention Type DRUG

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Interventions

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Seretide 250(8puffs) via Evohaler actuator

8 puffs of Seretide250/Placebo via Evohaler actuator

Intervention Type DRUG

Seretide 250 (8 puffs)/placebo via Volumatic spacer

8 puffs of Seretide 250/placebo via volumatic spacer

Intervention Type DRUG

Seretide 250/placebo 8 puffs via Aerochamber Plus spacer

Seretide 250/placebo 8 puffs via Aerochamber Plus

Intervention Type DRUG

Seretide 250/placebo via Synchro-Breathe

Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Intervention Type DRUG

Other Intervention Names

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Advair Advair Advair Advair

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes