We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Investigational drugs no longer available)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562093
First Posted: March 23, 2012
Last Update Posted: August 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital
March 21, 2012
March 23, 2012
August 31, 2016
January 2012
June 2016   (Final data collection date for primary outcome measure)
forced expiratory volume [ Time Frame: up to 12 weeks ]
spirometry, methacholine and mannitol
Same as current
Complete list of historical versions of study NCT01562093 on ClinicalTrials.gov Archive Site
  • 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)
  • 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)
  • wheeze [ Time Frame: up to 12 weeks ]
    Pulmotrack wheeze meter
  • subjective improvement in asthma symptomatology [ Time Frame: up to 12 weeks ]
    Asthma Control Questionnaire
Same as current
Not Provided
Not Provided
 
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • 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
  • 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
  • Experimental: local nasal steroids
    Intervention: Drug: corticosteroid nasal spray
  • Placebo Comparator: placebo
    Intervention: Drug: placebo nasal spray
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
 
NCT01562093
2009/158
No
Not Provided
Not Provided
St. Olavs Hospital
St. Olavs Hospital
Norwegian University of Science and Technology
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
St. Olavs Hospital
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP