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

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Seretide 250(8puffs) via Evohaler actuator Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer Drug: Seretide 250/placebo via Synchro-Breathe	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Asthma Potassium

U.S. FDA Resources

Further study details as provided by University of Dundee:

Primary Outcome Measures:

Overnight Urinary Cortisol creatinine ratio [ Time Frame: within 24 hours after study drug inhalation ] [ Designated as safety issue: Yes ]
This outcome measure evaluates the amount of cortisol being suppressed after inhaled steroid administration. This helps to assess the systemic effect of steroid inhalation and therefore the propensity for adrenal suppression which is a noted adverse effect with high dose inhaled steroids

Secondary Outcome Measures:

Serum Potassium [ Time Frame: 60 minutes post treatment ] [ Designated as safety issue: Yes ]
The serum potassium is monitored 60 minutes post study drug inhalation to assess the systemic beta-2-adrenoreceptor metabolic response. Long acting beta agonists like Salmeterol exhibit dose related reduction in serum potassium.

Enrollment:	19
Study Start Date:	November 2009
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Evohaler	Drug: Seretide 250(8puffs) via Evohaler actuator 8 puffs of Seretide250/Placebo via Evohaler actuator Other Name: Advair Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer 8 puffs of Seretide 250/placebo via volumatic spacer Other Name: Advair Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer Seretide 250/placebo 8 puffs via Aerochamber Plus Other Name: Advair Drug: Seretide 250/placebo via Synchro-Breathe Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device Other Name: Advair
Experimental: Volumatic spacer	Drug: Seretide 250(8puffs) via Evohaler actuator 8 puffs of Seretide250/Placebo via Evohaler actuator Other Name: Advair Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer 8 puffs of Seretide 250/placebo via volumatic spacer Other Name: Advair Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer Seretide 250/placebo 8 puffs via Aerochamber Plus Other Name: Advair Drug: Seretide 250/placebo via Synchro-Breathe Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device Other Name: Advair
Experimental: Aerochamber Plus	Drug: Seretide 250(8puffs) via Evohaler actuator 8 puffs of Seretide250/Placebo via Evohaler actuator Other Name: Advair Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer 8 puffs of Seretide 250/placebo via volumatic spacer Other Name: Advair Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer Seretide 250/placebo 8 puffs via Aerochamber Plus Other Name: Advair Drug: Seretide 250/placebo via Synchro-Breathe Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device Other Name: Advair
Experimental: Synchro-Breathe	Drug: Seretide 250(8puffs) via Evohaler actuator 8 puffs of Seretide250/Placebo via Evohaler actuator Other Name: Advair Drug: Seretide 250 (8 puffs)/placebo via Volumatic spacer 8 puffs of Seretide 250/placebo via volumatic spacer Other Name: Advair Drug: Seretide 250/placebo 8 puffs via Aerochamber Plus spacer Seretide 250/placebo 8 puffs via Aerochamber Plus Other Name: Advair Drug: Seretide 250/placebo via Synchro-Breathe Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device Other Name: Advair

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Volunteers
Male or female 18-65
Informed Consent
Ability to comply with the requirements of the protocol

Exclusion Criteria:

No respiratory disease
Smokers
Recent respiratory tract infection (2 months).
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.
Any significant abnormal laboratory result as deemed by the investigators
Pregnancy, planned pregnancy or lactation
Known or suspected contra-indication to any of the IMP's
Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01194700

Locations

United Kingdom
Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School
Dundee, Tayside, United Kingdom, DD1 9SY

Sponsors and Collaborators

University of Dundee

Investigators

Principal Investigator:	Arun Nair	University of Dundee
Study Director:	Brian J Lipworth	University of Dundee

More Information

No publications provided

Responsible Party:	Arun Nair( Prinicpal Investigator), Sponsor represenative(Catrina Forde, UOD), University of Dundee
ClinicalTrials.gov Identifier:	NCT01194700 History of Changes
Other Study ID Numbers:	NAI008, 2007-003627-20
Study First Received:	September 2, 2010
Last Updated:	September 17, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:

lung bioavailability
asthma
seretide
Spacer

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Fluticasone, salmeterol drug combination
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013