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

This study has been completed.
Sponsor:
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT01194700
First received: September 2, 2010
Last updated: September 17, 2010
Last verified: December 2009
  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:


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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014