Clinical trial NCT00903227: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Allergic Rhinitis
Keywords: Asthma
Allergic rhinitis
fluticasone
methacholine
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: methacholine PC20
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
Secondary outcomes:
measure: Spirometry
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Juniper AQLQ
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Fractionated Nitric Oxide
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: serum ECP
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: blood eosinophils
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Overnight urinary cortisol creatinine
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Peak Nasal Inspiratory Flow rate
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Nasal Nitric Oxide
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
measure: Juniper mini RQLQ
timeFrame: 0, 2, 4, 6, 8, 10, 12 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee
state: Angus
Study officials:
affiliation: University of Dundee
name: Arun Nair, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: Brian Lipworth, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.