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Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Primary Purpose

Asthma, Allergic Rhinitis

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Fluticasone Evohaler pMDI

Placebo

Fluticasone Evohaler

Placebo intranasal spray

fluticasone propionate (Flixonase®)

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Allergic rhinitis, fluticasone, methacholine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Low Dose

Combined

High dose

Arm Description

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.

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).

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.

Outcomes

Primary Outcome Measures

methacholine PC20

Secondary Outcome Measures

Spirometry

Juniper AQLQ

Fractionated Nitric Oxide

serum ECP

blood eosinophils

Overnight urinary cortisol creatinine

Peak Nasal Inspiratory Flow rate

Nasal Nitric Oxide

Juniper mini RQLQ

Full Information

NCT ID

NCT00903227

First Posted

May 14, 2009

Last Updated

October 10, 2019

Sponsor

University of Dundee

1. Study Identification

Unique Protocol Identification Number

NCT00903227

Brief Title

Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

December 2006 (undefined)

Primary Completion Date

August 2008 (Actual)

Study Completion Date

August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Dundee

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma, Allergic Rhinitis

Keywords

Asthma, Allergic rhinitis, fluticasone, methacholine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low Dose

Arm Type

Experimental

Arm Description

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.

Arm Title

Combined

Arm Type

Experimental

Arm Description

Arm Title

High dose

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Fluticasone Evohaler pMDI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

1 puff of inhaled Placebo twice a day

Intervention Type

Drug

Intervention Name(s)

Fluticasone Evohaler

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo intranasal spray

Intervention Description

placebo intranasal spray 2 squirts each nostril once a day

Intervention Type

Drug

Intervention Name(s)

fluticasone propionate (Flixonase®)

Intervention Description

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Primary Outcome Measure Information:

Title

methacholine PC20

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Secondary Outcome Measure Information:

Title

Spirometry

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Juniper AQLQ

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Fractionated Nitric Oxide

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

serum ECP

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

blood eosinophils

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Overnight urinary cortisol creatinine

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Peak Nasal Inspiratory Flow rate

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Nasal Nitric Oxide

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

Title

Juniper mini RQLQ

Time Frame

0, 2, 4, 6, 8, 10, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arun Nair, MBBS

Organizational Affiliation

University of Dundee

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brian Lipworth, MD

Organizational Affiliation

University of Dundee

Official's Role

Study Director

Facility Information:

Facility Name

Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee

City

Dundee

State/Province

Angus

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

9042071

Citation

Corren J. Allergic rhinitis and asthma: how important is the link? J Allergy Clin Immunol. 1997 Feb;99(2):S781-6. doi: 10.1016/s0091-6749(97)70127-1.

Results Reference

background

PubMed Identifier

3131406

Citation

Reed CE, Marcoux JP, Welsh PW. Effects of topical nasal treatment on asthma symptoms. J Allergy Clin Immunol. 1988 May;81(5 Pt 2):1042-7. doi: 10.1016/0091-6749(88)90177-7.

Results Reference

background

PubMed Identifier

15932376

Citation

Dahl R, Nielsen LP, Kips J, Foresi A, Cauwenberge P, Tudoric N, Howarth P, Richards DH, Williams M, Pauwels R; SPIRA Study Group. Intranasal and inhaled fluticasone propionate for pollen-induced rhinitis and asthma. Allergy. 2005 Jul;60(7):875-81. doi: 10.1111/j.1398-9995.2005.00819.x.

Results Reference

background

PubMed Identifier

18691301

Citation

Bousquet J, Reid J, van Weel C, Baena Cagnani C, Canonica GW, Demoly P, Denburg J, Fokkens WJ, Grouse L, Mullol K, Ohta K, Schermer T, Valovirta E, Zhong N, Zuberbier T. Allergic rhinitis management pocket reference 2008. Allergy. 2008 Aug;63(8):990-6. doi: 10.1111/j.1398-9995.2008.01642.x.

Results Reference

background

PubMed Identifier

19804441

Citation

Nair A, Vaidyanathan S, Clearie K, Williamson P, Meldrum K, Lipworth BJ. Steroid sparing effects of intranasal corticosteroids in asthma and allergic rhinitis. Allergy. 2010 Mar;65(3):359-67. doi: 10.1111/j.1398-9995.2009.02187.x. Epub 2009 Oct 5. Erratum In: Allergy. 2017 Sep;72 (9):1431.

Results Reference

result

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Steroid Sparing Effect of Nasal Corticosteroid In Asthma And Rhinitis

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