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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005557-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone Evohaler pMDI | Drug | One puff of inhaled Fluticasone Evohaler pMDI 50 µg twice a day (Total FP dose 100 µg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| methacholine PC20 | 0, 2, 4, 6, 8, 10, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Spirometry | 0, 2, 4, 6, 8, 10, 12 weeks | |
| Juniper AQLQ | 0, 2, 4, 6, 8, 10, 12 weeks | |
| Fractionated Nitric Oxide |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arun Nair, MBBS | University of Dundee | Principal Investigator |
| Brian Lipworth, MD | University of Dundee | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asthma and Allergy Research Group, Ninewells Hospital and University of Dundee | Dundee | Angus | DD1 9SY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9042071 | Background | 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. | |
| 3131406 | Background | 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. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Drug | 1 puff of inhaled Placebo twice a day |
|
| Fluticasone Evohaler | Drug | One puff of inhaled Fluticasone Evohaler 250µg twice a day (Total daily FP dose 500µg) |
|
| Placebo intranasal spray | Drug | placebo intranasal spray 2 squirts each nostril once a day |
|
| fluticasone propionate (Flixonase®) | Drug | intranasal fluticasone propionate (Flixonase®) 50ug 2 squirts |
|
| 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 |
| Overnight urinary cortisol creatinine | 0, 2, 4, 6, 8, 10, 12 weeks |
| Peak Nasal Inspiratory Flow rate | 0, 2, 4, 6, 8, 10, 12 weeks |
| Nasal Nitric Oxide | 0, 2, 4, 6, 8, 10, 12 weeks |
| Juniper mini RQLQ | 0, 2, 4, 6, 8, 10, 12 weeks |
| 15932376 | Background | 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. |
| 18691301 | Background | 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. |
| 19804441 | Result | 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. |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |