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Investigational drugs no longer available
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
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In this study we will investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms.
Although up to 95% of asthma patients suffer from blocked nose, the majority of these patients do not undergo systematic assessment and treatment for nasal blockage. This is unfortunate, as optimal diagnosis and treatment of nasal blockage in asthmatics can reduce asthma morbidity and use of anti-asthmatic medication.
The "Unified Airways" concept considers the upper and lower airways as one unified airway. In recent years there has been increasing awareness about the relationship between inflammation in the upper and lower airways, with disease in the upper airways affecting the lungs through neurological, immunological and mechanical mechanisms, resulting in asthmatic symptoms.
Conditioning and filtration of the inspired air are important functions of the nose, and oral breathing results in inhalation of poorly conditioned and filtered air in to an already inflamed lower airway. Together will these mechanisms lead to a worsening of the asthmatic disease.
The aim of this study is to investigate the effect of intranasal corticosteroid therapy, which is known to reduce mucosal inflammation and nasal blockage, on asthmatic symptoms. The primary outcome variable is improvement in asthma symptomatology. The secondary outcome variables are improvement in nasal blockage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| local nasal steroids | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| corticosteroid nasal spray | Drug | fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| forced expiratory volume | spirometry, methacholine and mannitol | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| improvement in nasal blockage | Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF) | up to 12 weeks |
| nasal and exhaled NO | NO level in the nasal and exhaled air is measured by the chemiluminescence method with a LR 2000 nitric oxide gas analyser (Logan Research, Rochester, UK) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sverre Steinsvåg, MD prof | St. Olavs Hospital | Study Director |
| Malcolm Sue-Chu, MD | St Olavs University Hospital Trondheim | Principal Investigator |
| Vegard Bugten, MD | St Olavs University Hospital Trondheim | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olav University Hospital | Trondheim | Norway |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| placebo nasal spray | Drug | formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months |
|
| up to 12 weeks |
| wheeze | Pulmotrack wheeze meter | up to 12 weeks |
| subjective improvement in asthma symptomatology | Asthma Control Questionnaire | up to 12 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |