Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Primary Purpose
Asthma
Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
corticosteroid nasal spray
placebo nasal spray
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Adrenal Cortex Hormones, Spirometry, Administration, Intranasal, Nasal blockage, Nasal sprays
Eligibility Criteria
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
Sites / Locations
- St Olav University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
local nasal steroids
placebo
Arm Description
Outcomes
Primary Outcome Measures
forced expiratory volume
spirometry, methacholine and mannitol
Secondary Outcome Measures
improvement in nasal blockage
Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
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)
wheeze
Pulmotrack wheeze meter
subjective improvement in asthma symptomatology
Asthma Control Questionnaire
Full Information
NCT ID
NCT01562093
First Posted
March 21, 2012
Last Updated
August 30, 2016
Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01562093
Brief Title
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Official Title
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Investigational drugs no longer available
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital
Collaborators
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Adrenal Cortex Hormones, Spirometry, Administration, Intranasal, Nasal blockage, Nasal sprays
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
local nasal steroids
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
corticosteroid nasal spray
Other Intervention Name(s)
Avamys
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo nasal spray
Intervention Description
formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months
Primary Outcome Measure Information:
Title
forced expiratory volume
Description
spirometry, methacholine and mannitol
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
improvement in nasal blockage
Description
Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
Time Frame
up to 12 weeks
Title
nasal and exhaled NO
Description
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)
Time Frame
up to 12 weeks
Title
wheeze
Description
Pulmotrack wheeze meter
Time Frame
up to 12 weeks
Title
subjective improvement in asthma symptomatology
Description
Asthma Control Questionnaire
Time Frame
up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sverre Steinsvåg, MD prof
Organizational Affiliation
St. Olav University Hospital, Trondheim, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Malcolm Sue-Chu, MD
Organizational Affiliation
St Olavs University Hospital Trondheim
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vegard Bugten, MD
Organizational Affiliation
St Olavs University Hospital Trondheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Olav University Hospital
City
Trondheim
Country
Norway
12. IPD Sharing Statement
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Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
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