Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
NCT ID: NCT01562093
Last Updated: 2016-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2012-01-31
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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local nasal steroids
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
placebo
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
Interventions
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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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>18 years
Exclusion Criteria
* systemic disease with nasal manifestations
* cancer of the nose
* currently receiving cancer therapy
* previous nose surgery
18 Years
65 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Sverre Steinsvåg, MD prof
Role: STUDY_DIRECTOR
St. Olav University Hospital, Trondheim, Norway
Malcolm Sue-Chu, MD
Role: PRINCIPAL_INVESTIGATOR
St Olavs University Hospital Trondheim
Vegard Bugten, MD
Role: PRINCIPAL_INVESTIGATOR
St Olavs University Hospital Trondheim
Locations
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St Olav University Hospital
Trondheim, , Norway
Countries
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Other Identifiers
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2009/158
Identifier Type: -
Identifier Source: org_study_id
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