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

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ClinicalTrials.gov Identifier: NCT01562093
Recruitment Status : Terminated (Investigational drugs no longer available)
First Posted : March 23, 2012
Last Update Posted : August 31, 2016
Sponsor:
Collaborator:
Norwegian University of Science and Technology
Information provided by (Responsible Party):
St. Olavs Hospital

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE March 23, 2012
Last Update Posted Date August 31, 2016
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
forced expiratory volume [ Time Frame: up to 12 weeks ]
spirometry, methacholine and mannitol
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion
Official Title  ICMJE Effect of Intranasal Corticosteroids on Pulmonary Symptoms in Asthmatics With Nasal Congestion, a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: local nasal steroids
    Intervention: Drug: corticosteroid nasal spray
  • Placebo Comparator: placebo
    Intervention: Drug: placebo nasal spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 30, 2016)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 21, 2012)
60
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01562093
Other Study ID Numbers  ICMJE 2009/158
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Olavs Hospital
Study Sponsor  ICMJE St. Olavs Hospital
Collaborators  ICMJE Norwegian University of Science and Technology
Investigators  ICMJE
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
PRS Account St. Olavs Hospital
Verification Date August 2016

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