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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by St. Olavs Hospital
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT01562093
First received: March 21, 2012
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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 Intervention
Asthma
Drug: corticosteroid nasal spray
Drug: placebo nasal spray

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • forced expiratory volume [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    spirometry, methacholine and mannitol


Secondary Outcome Measures:
  • improvement in nasal blockage [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Sino-Nasal Outcome Test 20 (SNOT20), acoustic rhinometry (AR) and peak nasal inspiratory flow (PNIF)

  • nasal and exhaled NO [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    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)

  • wheeze [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Pulmotrack wheeze meter

  • subjective improvement in asthma symptomatology [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Asthma Control Questionnaire


Estimated Enrollment: 60
Study Start Date: January 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: local nasal steroids Drug: corticosteroid nasal spray
fluticasone furuoate 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

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562093

Contacts
Contact: Wenche M Thorstensen, MD wenche.m.thorstensen@ntnu.no
Contact: Malcolm Sue-Chu, MD msuechu@online.no

Locations
Norway
St Olav University Hospital Recruiting
Trondheim, Norway
Contact: Wenche M Thorstensen, MD       wenche.m.thorstensen@ntnu.no   
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

No publications provided

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT01562093     History of Changes
Other Study ID Numbers: 2009/158
Study First Received: March 21, 2012
Last Updated: April 16, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
Adrenal Cortex Hormones
Spirometry
Administration, Intranasal
Nasal blockage
Nasal sprays

Additional relevant MeSH terms:
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014