Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial|
- forced expiratory volume [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]spirometry, methacholine and mannitol
- improvement in nasal blockage [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
- nasal and exhaled NO [ Time Frame: up to 12 weeks ] [ Designated as safety issue: 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)
- wheeze [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]Pulmotrack wheeze meter
- subjective improvement in asthma symptomatology [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]Asthma Control Questionnaire
|Study Start Date:||January 2012|
|Study Completion Date:||June 2016|
|Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
|Experimental: local nasal steroids||
Drug: corticosteroid 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
Other Name: Avamys
|Placebo Comparator: placebo||
Drug: placebo 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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562093
|St Olav University Hospital|
|Study Director:||Sverre Steinsvåg, MD prof||St Olav University Hospital, Trondheim, Norway|
|Principal Investigator:||Malcolm Sue-Chu, MD||St Olavs University Hospital Trondheim|
|Principal Investigator:||Vegard Bugten, MD||St Olavs University Hospital Trondheim|