Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Information source: St. Olavs Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: corticosteroid nasal spray (Drug); placebo nasal spray (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: St. Olavs Hospital Official(s) and/or principal investigator(s): Sverre Steinsvåg, MD prof, Study Director, Affiliation: St Olav University Hospital, Trondheim, Norway Malcolm Sue-Chu, MD, Principal Investigator, Affiliation: St Olavs University Hospital Trondheim Vegard Bugten, MD, Principal Investigator, Affiliation: St Olavs University Hospital Trondheim
Overall contact: Wenche M Thorstensen, MD, Email: wenche.m.thorstensen@ntnu.no
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.
Clinical Details
Official title: Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: forced expiratory volume
Secondary outcome: improvement in nasal blockagenasal and exhaled NO wheeze subjective improvement in asthma symptomatology
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Wenche M Thorstensen, MD, Email: wenche.m.thorstensen@ntnu.no
St Olav University Hospital, Trondheim, Norway; Recruiting Wenche M Thorstensen, MD, Email: wenche.m.thorstensen@ntnu.no
Additional Information
Starting date: January 2012
Last updated: April 30, 2015
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