Clinical trial NCT01562093: 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
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Keywords: Adrenal Cortex Hormones
Spirometry
Administration, Intranasal
Nasal blockage
Nasal sprays
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2012-03-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: forced expiratory volume
timeFrame: up to 12 weeks
Secondary outcomes:
measure: improvement in nasal blockage
timeFrame: up to 12 weeks
measure: nasal and exhaled NO
timeFrame: up to 12 weeks
measure: wheeze
timeFrame: up to 12 weeks
measure: subjective improvement in asthma symptomatology
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olav University Hospital
Study officials:
affiliation: St. Olav University Hospital, Trondheim, Norway
name: Sverre Steinsvåg, MD prof
role: STUDY_DIRECTOR
affiliation: St Olavs University Hospital Trondheim
name: Malcolm Sue-Chu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Olavs University Hospital Trondheim
name: Vegard Bugten, MD
role: PRINCIPAL_INVESTIGATOR
References: