Fluticasone and Salmeterol in Allergic Rhinitis

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the population worldwide. It has been reported as being one of the 10 most common causes for attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the nose induced by an IgE mediated inflammation following allergen exposure of the membranes lining the nose and is characterized by varying combinations of nasal symptoms including sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis. The question therefore arises as to whether salmeterol exhibits such synergistic activity in the nose in terms of potentiating the steroid response of fluticasone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Treatments: Fluticasone; Salmeterol Xinafoate

Criteria

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

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.