NCT00903227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4 asthma

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 18, 2009

Completed
Last Updated

October 16, 2019

Status Verified

October 1, 2019

Enrollment Period

1.7 years

First QC Date

May 14, 2009

Last Update Submit

October 10, 2019

Conditions

AsthmaAllergic Rhinitis

Keywords

AsthmaAllergic rhinitisfluticasonemethacholine

Outcome Measures

Primary Outcomes (1)

  • methacholine PC20

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

Secondary Outcomes (9)

  • Spirometry

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

  • Juniper AQLQ

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

  • Fractionated Nitric Oxide

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

  • serum ECP

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

  • blood eosinophils

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

  • +4 more secondary outcomes

Study Arms (3)

Low Dose

EXPERIMENTAL

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 pMDIDrug: PlaceboDrug: Placebo intranasal spray

Combined

EXPERIMENTAL

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 pMDIDrug: PlaceboDrug: fluticasone propionate (Flixonase®)

High dose

EXPERIMENTAL

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: PlaceboDrug: Fluticasone EvohalerDrug: Placebo intranasal spray

Interventions

Fluticasone Evohaler pMDIDRUG

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

CombinedLow Dose
PlaceboDRUG

1 puff of inhaled Placebo twice a day

CombinedHigh doseLow Dose
Fluticasone EvohalerDRUG

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

High dose
Placebo intranasal sprayDRUG

placebo intranasal spray 2 squirts each nostril once a day

High doseLow Dose
fluticasone propionate (Flixonase®)DRUG

intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts

Combined

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dundee, Angus, DD1 9SY, United Kingdom

Location

Related Publications (5)

  • 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.

    PMID: 9042071BACKGROUND

  • 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.

    PMID: 3131406BACKGROUND

  • 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.

    PMID: 15932376BACKGROUND

  • 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.

    PMID: 18691301BACKGROUND

  • 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.

    PMID: 19804441RESULT

MeSH Terms

Conditions

AsthmaRhinitis, Allergic

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRhinitisNose DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Arun Nair, MBBS

    University of Dundee

    PRINCIPAL INVESTIGATOR

  • Brian Lipworth, MD

    University of Dundee

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2009

First Posted

May 18, 2009

Study Start

December 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 16, 2019

Record last verified: 2019-10

Locations

GB(1)