Evaluation Effects of Nasal Nitric Oxide Measurements Are Associated With Atopy Status in Chronic Nasal Inflammation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 |
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.
Contacts and Locations
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 June 18, 2013