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

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brian J Lipworth
• Treatments: Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

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