Asthma
Conditions
Keywords
Adrenal Cortex Hormones, Spirometry, Administration, Intranasal, Nasal blockage, Nasal sprays
Brief summary
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.
Detailed description
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.
Interventions
DRUGcorticosteroid nasal spray
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
DRUGplacebo nasal spray
formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months
Sponsors
Norwegian University of Science and Technology
St. Olavs Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* asthma (according to British Thoracic Society guideline) * \>18 years
Exclusion criteria
* pregnancy * systemic disease with nasal manifestations * cancer of the nose * currently receiving cancer therapy * previous nose surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| forced expiratory volume | up to 12 weeks | spirometry, methacholine and mannitol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement in nasal blockage | up to 12 weeks | Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF) |
| nasal and exhaled NO | up to 12 weeks | 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) |
| wheeze | up to 12 weeks | Pulmotrack wheeze meter |
| subjective improvement in asthma symptomatology | up to 12 weeks | Asthma Control Questionnaire |
Countries
Norway
Outcome results
None listed