A proof of concept study to evaluate differential tachyphylaxis of a1 and a2 adrenoreceptor mediated decongestant response to oxymetazoline and its acute reversal by corticosteroid in healthy volunteers - Differential adreneoreceptor mediated tachyphylaxis and upregulatio

Phase 1

• Conditions: This is a proof of concept trial on Healthy Volunteers to evaluate the tolerance of nasal adrenoreceptors to prolonged decongestant use and upregulation by intranasal steroids. The medical condition investigated would be tachyphylaxis.; MedDRA version: 9.1Level: LLTClassification code 10043087Term: Tachyphylaxis

• Registration Number: EUCTR2007-003194-82-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-31
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

1.Male of Female aged 18-65 years.
2.Healthy volunteers with a negative history of seasonal or perennial nasal symptoms other than occasional common colds. Atopy will not preclude inclusion into the study as long as pts have no nasal symptoms
3.Current non-smokers (ex-smokers for greater than 6 months duration with a total smoking history of less than 5 pack-years will be eligible)
4.PNIF > 100L/min (best effort of 3) and reversibility with OXY 2 squirts in each nostril (20 min reading) > 20L/min.
5.Ability to give a written informed consent.
6.Ability and willingness to comply with the requirements of the protocol.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Deviated nasal septum = 50% (50% reduction in expected cavity cross-sectional area).
2.The use of oral corticosteroids within the last 3 months.
3.Recent respiratory tract/sinus infection within the last 2 months. .
4.Pregnancy, planned pregnancy or lactation.
5.Any significant abnormal laboratory result as deemed by the investigators.
6.Known or suspected hypersensitivity to any of the IMP’s.
7.Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may interfere with the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified