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

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. Identifier: NCT01295866
Recruitment Status : Completed
First Posted : February 15, 2011
Last Update Posted : February 15, 2011
Information provided by:
Beijing Tongren Hospital

Brief Summary:
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 or disease Intervention/treatment
Hypersensitivity Rhinitis Respiratory Tract Diseases Nasal Polyps Nitric Oxide Device: nasal nitric oxide

Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Study Start Date : January 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

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U.S. FDA Resources

Group/Cohort Intervention/treatment
nasal nitric oxide, atypy status Device: nasal nitric oxide

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

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.

Responsible Party: Demin Han, Beijing Tongren Hospital Identifier: NCT01295866     History of Changes
Other Study ID Numbers: 1129
First Posted: February 15, 2011    Key Record Dates
Last Update Posted: February 15, 2011
Last Verified: January 2011

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

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