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

February 14, 2011 updated by: Beijing Tongren Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 11, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2011

Last Update Submitted That Met QC Criteria

February 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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