Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

October 10, 2019 updated by: University of Dundee

A Proof Of Concept Study To Assess The Steroid Sparing Effect Of Combined Nasal And Inhaled Corticosteroid In Patients With Asthma And Persistent Rhinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Angus
      • Dundee, Angus, United Kingdom, DD1 9SY
        • Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild to moderate atopic asthmatics with FEV1 ≥ 60% on ≤ 1000 ug BDP and concomitant persistent allergic rhinitis (SPT +ve and PC20 < 4 mg/ml)
  • Male or female aged 18-65 years
  • Informed Consent
  • Ability to comply with the requirements of the protocol

Exclusion Criteria:

  • Severe asthmatics as defined by an FEV1 ≤ 60% or PEF variability > 30% or with continual daytime or nocturnal symptoms.
  • Nasal Polyposis grade 2/3, deviated nasal septum ≥ 50%
  • The use of oral corticosteroids within the last 3 months
  • Recent respiratory tract infection (2 months)
  • Significant concomitant respiratory disease
  • Any other significant medical condition or investigation which may jeopardise the safety of the participant or the conduct of the protocol
  • Any significant abnormal laboratory result as deemed by the investigators
  • Pregnancy, planned pregnancy or lactation
  • Known or suspected contra-indication to any of the IMP's
  • Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Dose
One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) and 1 puff of inhaled Placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
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: Placebo intranasal spray
placebo intranasal spray 2 squirts each nostril once a day
Experimental: Combined
One puff of inhaled fluticasone propionate Evohaler pMDI 50 µg twice a day (Total daily FP dose 100 µg) and 1 puffs of Placebo twice a day with intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts each nostril once a day (i.e. total intranasal FP daily dose 200ug).
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 propionate (Flixonase®)
intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts
Experimental: High dose
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) and 1 puff of inhaled placebo twice a day with placebo intranasal spray 2 squirts each nostril once a day.
Drug: Placebo
1 puff of inhaled Placebo twice a day
Drug: Placebo intranasal spray
placebo intranasal spray 2 squirts each nostril once a day
Drug: Fluticasone Evohaler
One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
methacholine PC20
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Spirometry
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Juniper AQLQ
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Fractionated Nitric Oxide
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
serum ECP
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
blood eosinophils
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Overnight urinary cortisol creatinine
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Peak Nasal Inspiratory Flow rate
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Nasal Nitric Oxide
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks
Juniper mini RQLQ
Time Frame: 0, 2, 4, 6, 8, 10, 12 weeks
0, 2, 4, 6, 8, 10, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Dundee

Investigators

  • Principal Investigator: Arun Nair, MBBS, University of Dundee
  • Study Director: Brian Lipworth, MD, University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

May 14, 2009

First Submitted That Met QC Criteria

May 14, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Actual)

October 16, 2019

Last Update Submitted That Met QC Criteria

October 10, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAI03
  • 2005-005557-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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