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

• ClinicalTrials.gov Identifier: NCT01562093
• Recruitment Status: Terminated
• First Posted: March 23, 2012
• Last Update Posted: August 31, 2016
• Sponsor: St. Olavs Hospital
• Collaborator: Norwegian University of Science and Technology
• Information provided by (Responsible Party): St. Olavs Hospital

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: corticosteroid nasal spray; Drug: placebo nasal spray	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
• Study Start Date: January 2012
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: June 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: local nasal steroids	Drug: corticosteroid nasal spray; 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; Other Name: Avamys
Placebo Comparator: placebo	Drug: placebo nasal spray; formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months

Outcome Measures

Primary Outcome Measures :

1. forced expiratory volume [ Time Frame: up to 12 weeks ]
   spirometry, methacholine and mannitol

Secondary Outcome Measures :

1. improvement in nasal blockage [ Time Frame: up to 12 weeks ]
   Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)
2. nasal and exhaled NO [ Time Frame: 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)
3. wheeze [ Time Frame: up to 12 weeks ]
   Pulmotrack wheeze meter
4. subjective improvement in asthma symptomatology [ Time Frame: up to 12 weeks ]
   Asthma Control Questionnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Norway

St Olav University Hospital

Trondheim, Norway

Sponsors and Collaborators

St. Olavs Hospital

Norwegian University of Science and Technology

Investigators

• Study Director: Sverre Steinsvåg, MD prof; St Olav University Hospital, Trondheim, Norway
• Principal Investigator: Malcolm Sue-Chu, MD; St Olavs University Hospital Trondheim
• Principal Investigator: Vegard Bugten, MD; St Olavs University Hospital Trondheim

More Information

• Responsible Party: St. Olavs Hospital
• ClinicalTrials.gov Identifier: NCT01562093
• Other Study ID Numbers: 2009/158
• First Posted: March 23, 2012
• Last Update Posted: August 31, 2016
• Last Verified: August 2016

Keywords provided by St. Olavs Hospital:

Adrenal Cortex Hormones; Spirometry; Administration, Intranasal; Nasal blockage; Nasal sprays

Additional relevant MeSH terms:

Signs and Symptoms, Respiratory