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Fluticasone and Salmeterol in Allergic Rhinitis

NCT01388595 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2019-10-16

No results posted yet for this study

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.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

FLUTICASONE PROPRIONATE

1\. Fluticasone Propionate (FP) Product name: Flixotide Evohaler® Manufacturer: Allan and Hanbury's Active ingredients: Fluticasone Propionate Propellant: HFA 134a Dose: 250μg per actuation giving a total dose of 500µg per day through the spacer device with the customised nasal adaptor.

DRUG

Salmeterol

Salmeterol Product Name: Serevent® Manufacturer: Allan and Hanbury's Active ingredients: Salmetrol Xinafoate Propellant: HFA 134a Dose: 25μg per actuation giving a total dose of 50µg per day through the spacer device with the customised nasal adaptor

DRUG

PLACEBO

4\. Placebo inhaler to SM, FP, SM+FP Manufacturer: Cipla Ltd Active ingredients: None Propellants: HFA 134a Imported \& QP release tested in UK : DHP Clinical supplies, Powys, UK

Sponsors & Collaborators

  • University of Dundee

    lead OTHER

Principal Investigators

  • Brian J Lipworth, MD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388595 on ClinicalTrials.gov