Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Drug: corticosteroid nasal spray Drug: placebo nasal spray |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: local nasal steroids |
Drug: corticosteroid nasal spray
fluticasone furuoate 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Wenche M Thorstensen, MD | wenche.m.thorstensen@ntnu.no | |
| Contact: Malcolm Sue-Chu, MD | msuechu@online.no |
| Norway | |
| St Olav University Hospital | Recruiting |
| Trondheim, Norway | |
| Contact: Wenche M Thorstensen, MD wenche.m.thorstensen@ntnu.no | |
| 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 |
More Information
No publications provided
| Responsible Party: | St. Olavs Hospital |
| ClinicalTrials.gov Identifier: | NCT01562093 History of Changes |
| Other Study ID Numbers: | 2009/158 |
| Study First Received: | March 21, 2012 |
| Last Updated: | March 21, 2012 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by St. Olavs Hospital:
|
Adrenal Cortex Hormones Spirometry Administration, Intranasal Nasal blockage Nasal sprays |
Additional relevant MeSH terms:
|
Asthma Signs and Symptoms, Respiratory Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013