Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion

Not Applicable

Terminated

• Conditions: Asthma
• Interventions: Drug: corticosteroid nasal spray; Drug: placebo nasal spray

• Registration Number: NCT01562093
• Lead Sponsor: St. Olavs Hospital

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
local nasal steroids	corticosteroid nasal spray	-
placebo	placebo nasal spray	-

Primary Outcome Measures

Name	Time	Method
forced expiratory volume	up to 12 weeks	spirometry, methacholine and mannitol

Secondary Outcome Measures

Name	Time	Method
nasal and exhaled NO	up to 12 weeks	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)
improvement in nasal blockage	up to 12 weeks	Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
wheeze	up to 12 weeks	Pulmotrack wheeze meter
subjective improvement in asthma symptomatology	up to 12 weeks	Asthma Control Questionnaire

Trial Locations

Locations (1)

St Olav University Hospital; 🇳🇴 Trondheim, Norway