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Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

NCT00903227 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-10-16

No results posted yet for this study

Summary

Up to 40% of patients with asthma have allergic rhinitis and treatment of nasal airway inflammation with topical steroids improves the twitchiness of the airways (hyperresponsiveness) and overall asthma control. The use of inhaled corticosteroids reduces symptoms, severity of asthma attacks, improves quality of life, and reduces asthma related deaths. Similarly, treatment of rhinitis with nasal steroids reduces symptoms and improves quality of life. While there is evidence that combined treatment of the nose and the lungs with topical steroids improves symptoms and underlying inflammation, it is unclear whether such control can be achieved using a smaller dose of inhaled steroid in combination with nasal steroid. It is therefore the intention of this study to evaluate if combination steroid therapy (nose and lungs) has a steroid sparing effect in patients with asthma and rhinitis using sensitive markers of airway inflammation.

Conditions

Interventions

DRUG

Fluticasone Evohaler pMDI

One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg)

DRUG

Placebo

1 puff of inhaled Placebo twice a day

DRUG

Fluticasone Evohaler

One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

DRUG

Placebo intranasal spray

placebo intranasal spray 2 squirts each nostril once a day

DRUG

fluticasone propionate (Flixonase®)

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Sponsors & Collaborators

  • University of Dundee

    lead OTHER

Principal Investigators

  • Arun Nair, MBBS · University of Dundee

  • Brian Lipworth, MD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-08-31
Completion
2008-08-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT00903227 on ClinicalTrials.gov