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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

September 2, 2010
September 17, 2010
November 2009
December 2009   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01194700 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers
Comparative Study of Lung Bioavailability of HFA-Seretide Via Current Spacer Devices in Healthy Volunteers

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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: Evohaler
    Interventions:
    • 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
  • Experimental: Volumatic spacer
    Interventions:
    • 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
  • Experimental: Aerochamber Plus
    Interventions:
    • 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
  • Experimental: Synchro-Breathe
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01194700
NAI008, 2007-003627-20
No
Arun Nair( Prinicpal Investigator), Sponsor represenative(Catrina Forde, UOD), University of Dundee
University of Dundee
Not Provided
Principal Investigator: Arun Nair University of Dundee
Study Director: Brian J Lipworth University of Dundee
University of Dundee
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP