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

NCT01295866 | Completed DMC

• 1 other identifier: 1129
• Study Type: observational
• Target: 131
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity; Rhinitis; Respiratory Tract Diseases; Nasal Polyps; Nitric Oxide

Keywords

chronic nasal inflammation; nasal nitric oxide; atopy

Study Arms (1)

nasal nitric oxide, atypy status

Device: nasal nitric oxide

Interventions

nasal nitric oxide DEVICE

nasal nitric oxide, atypy status

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients with diagnosed atopic dermatitis and atopic asthma.
• Patients with diagnosed allergic rhinitis.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

MeSH Terms

Conditions

Hypersensitivity; Rhinitis; Respiratory Tract Diseases; Nasal Polyps

Condition Hierarchy (Ancestors)

Immune System Diseases; Respiratory Tract Infections; Infections; Nose Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2011
• First Posted: February 15, 2011
• Study Start: January 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 15, 2011

Record last verified: 2011-01