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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 blockage

nasal 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

Page last updated: August 23, 2015

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