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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194700
• Other study ID #: NAI008
• Secondary ID: 2007-003627-20
• Status: Completed
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Seretide 250(8puffs) via Evohaler actuator
8 puffs of Seretide250/Placebo via Evohaler actuator
• Seretide 250 (8 puffs)/placebo via Volumatic spacer
8 puffs of Seretide 250/placebo via volumatic spacer
• Seretide 250/placebo 8 puffs via Aerochamber Plus spacer
Seretide 250/placebo 8 puffs via Aerochamber Plus
• Seretide 250/placebo via Synchro-Breathe
Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device

Locations

Country	Name	City	State
United Kingdom	Asthma & Allergy Research Group, Department of cardiovascular & lung biology, Division of medicine, Ninewells Hospital & Medical School	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
Brian J Lipworth

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Nair A, McKinlay L, Williamson P, Short P, Burns P, Lipworth BJ. Comparative lung bioavailability of fluticasone/salmeterol via a breath-actuated spacer and conventional plastic spacers. Eur J Clin Pharmacol. 2011 Apr;67(4):355-363. doi: 10.1007/s00228-01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overnight Urinary Cortisol creatinine ratio	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	within 24 hours after study drug inhalation
Secondary	Serum Potassium	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.	60 minutes post treatment