A PROOF OF CONCEPT STUDY TO EVALAUTE EFFECTS INTRANASAL SALMETEROL AND FLUTICASONE GIVEN ALONE AND IN COMBINATION IN ALLERGIC RHINITIS - Effects of Intranasal Salmeterol and Fluticasone in Allergic Rhinitis

Phase 1

• Conditions: Allergic Rhinitis

• Registration Number: EUCTR2005-005523-34-GB
• Lead Sponsor: niversity of Dundee (Research & Innovation Services)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03-14
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Persistent allergic rhinitis without asthma.
2.Atopy to at least 1 allergen on SPT.
3.= 20% drop in PNIF following nasal AMP challenge
4.Male to female aged 18-65
5.Informed Consent
6.Ability to comply with 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.Severe allergic rhinitis as defined by those in whom there are symptoms
which significantly impair day to day activities on QOL questionnaire.
2.Nasal Polyposis grade 2/3, deviated nasal septum = 50%
3.PNIF < 60 litres/min
4.The use of oral corticosteroids within the last 3 months.
5.Recent respiratory tract / sinus infection (2 months).
6.Significant concomitant respiratory disease such as COPD, CF, ABPA,
bronchiectasis and active pulmonary tuberculosis.
7.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.
8.Any significant abnormal laboratory result as deemed by the investigators
9.Pregnancy, planned pregnancy or lactation
10.Known or suspected contra-indication to any of the IMP’s
11.Concomitant use of medicines (prescribed, over the counter or herbal) that
may interfere with the trial.

Study & Design

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