Evaluation Effects of Nasal Nitric Oxide Measurements Are Associated With Atopy Status in Chronic Nasal Inflammation

This study has been completed.
Sponsor:
Information provided by:
Beijing Tongren Hospital
ClinicalTrials.gov Identifier:
NCT01295866
First received: February 11, 2011
Last updated: February 14, 2011
Last verified: January 2011
  Purpose

Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists comparing nNO with established, larger accepted reference standard for chronic rhinosinusitis (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal inflammatory diseases has not been reported. The aim of our study was to determine the value of nNO in patients with chronic nasal inflammation, and to assess the relationship between nNO and atopic status in these patients. A total of 131 randomized patients suffering form chronic nonallergic nasal inflammation and 20 healthy volunteers were finally recruited. nNO was measured by NIOX devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal symptoms evaluation were used in the different diagnosis of chronic rhinitis (CR), CRS without nasal polyps (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was confirmed by skin prick test and serum IgE levels. Blood eosinophils were evaluated simultaneously. Relationships among nNO, various atopic characteristics and chronic nasal inflammation were evaluated.


Condition Intervention Phase
Hypersensitivity
Rhinitis
Respiratory Tract Diseases
Nasal Polyps
Nitric Oxide
Device: nasal nitric oxide
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort

Resource links provided by NLM:


Further study details as provided by Beijing Tongren Hospital:

Enrollment: 131
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
nasal nitric oxide, atypy status Device: nasal nitric oxide

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients were prospectively recruited from the Rhinology Clinics of the Otolaryngology, Head and Neck Surgery Department of Beijing TongRen Hospital from January 2010 to November 2010. After application of the exclusion criteria, the study was discussed with 410 consecutive patients with a primary diagnosis of chronic nonallergic nasal inflammation. Of these, 214 agreed to take part in, of which 83 were excluded (57 diagnosed as other nasal diseases such as fungal sinusitis, inverted papilloma and so on, 20 with obviously medicine history in the latest two weeks, and 6 refused to continue). Thus, 131 patients were randomized for inclusion and 20 normal adults were recruited as well in our study.

Criteria

Inclusion Criteria:

  • Diagnosed as CR, CRSsNP or CRSwNP based on the criteria of the European position paper.
  • Had at least two or more symptoms, one of which was either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), and/or facial pain/pressure, and/or reduction or loss of smell;
  • Either endoscopic signs of polyps and/or mucopurulent discharge primarily from the middle meatus and/or oedema/mucosal obstruction primarily in the middle meatus.

Exclusion Criteria:

  • Pregnancy, lactation, significant psychologic problems, inability to comply with study protocol, children under 18 years of age, systemic diseases affecting the nose (e.g., Wegener's granulomatosis, sarcoid, and acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit)
  • Use of systemic corticosteroids within 2 weeks before the inclusion visit, systemic diseases preventing participation in the study, and medical or surgical treatments influencing the study.
  • Patients with diagnosed atopic dermatitis and atopic asthma.
  • Patients with diagnosed allergic rhinitis.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Demin Han, Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT01295866     History of Changes
Other Study ID Numbers: 1129
Study First Received: February 11, 2011
Last Updated: February 14, 2011
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Tongren Hospital:
chronic nasal inflammation
nasal nitric oxide
atopy

Additional relevant MeSH terms:
Hypersensitivity
Inflammation
Nasal Polyps
Respiratory Tract Diseases
Rhinitis
Immune System Diseases
Pathologic Processes
Nose Diseases
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014