The Factors Associated With the Formation of Nasal polyp-a Case Control and Descriptive Study (ACAAGSONP)
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|ClinicalTrials.gov Identifier: NCT01278719|
Recruitment Status : Unknown
Verified April 2012 by Manjunath dandinarasaiah, Karnataka Institute of Medical Sciences.
Recruitment status was: Recruiting
First Posted : January 19, 2011
Last Update Posted : April 23, 2012
Nasal polyp is a significant health problem with a prevalence of 4%. It is increased in patients with asthma (7-15%), Cystic fibrosis (39-56%) or aspirin intolerance (36-96%).The quality of life (QOL) is worse than in patients suffering from hypertension, migraine, angina pectoris and head & neck cancer as per a previous study by Videler WJM et al.QOL is in comparison to chronic obstructive pulmonary disease.The reason why it develops in some and not in others remains unknown despite the disease being present for centuries.A definite relationship exists in patients with 'Sampter triad': Asthma, non steroidal anti-inflammatory drug sensitivity and nasal polyps. But not all patients with NSAID sensitivity have nasal polyps and vice verse.
Etiology is largely unknown despite the disease being present for centuries. Although the factors like wood stove exposure, smoking, allergic rhinitis, rhino sinusitis have been strongly implicated in literature from various studies, most data available is on ethmoidal polyps.The present study is an attempt to study the association of important risk factors with both antrochoanal(AC) and ethmoidal nasal polyps(EP).One study found that a significantly smaller proportion of the population with polyps were smokers compared to the unselected population (15% v/s 35%). But this is not confirmed by other studies.
Seven percent of asthma patients have nasal polyps and in non atopic asthma and late onset asthma, polyps are diagnosed more frequently (10-15%).Eosinophil numbers are significantly higher in nasal polyp tissue and further increased in patients with co-morbid asthma and aspirin sensitivity.
Nasal colonization in increased amounts was found by Staphylococcus aureus and presence of specific Immunoglobulin E directed against S.aureus enterotoxins was found. Rates of colonization and IgE presence in nasal polyp tissue were increased in subjects with nasal polyp associated with co-morbid asthma and aspirin sensitivity.
Nasal polyps are frequently found to run in families, suggesting a hereditary or with shared environmental factor. In the study by Rugina et al., more than half of 224 nasal polyp patients (52%) had a positive family history while the study by Greisener et.al, reported 14% of family history strongly suggesting hereditary factors in the pathogenesis of nasal polyps.
Some studies have found environmental factors like smoking and those using wood stove as a primary source of heating with the development of nasal polyps. The studies are contrasting.
There is presently a need of understanding the differences in the pathogenesis of antrochoanal polyp and ethmoidal nasal polyp clearly.There are hardly any concrete research performed on them to note the differences in the etiology and their pathogenesis. Hence the study is undertaken to extensively study the etiologies responsible for them and to note the differences.
|Condition or disease|
|Nasal Polyp Smoking Rhinosinusitis Allergic Rhinitis Deviated Nasal Septum ASA Intolerant Asthma|
The present study involves two parts. A case control study wherein the association of nasal polyps with various risk factors like smoking, wood stove exposure, allergic rhinitis, non vegetarian diet intake, rhino sinusitis, deviated nasal septum, occupational dust exposure and eosinophilia.This will be studied individually for antrochoanal and ethmoidal nasal polyps.Again the same will be studied with respect to the recurrent and non recurrent polyps.
A descriptive study focuses on the nasal polyp occurrence with respect to the age, sex, religion, socioeconomic status, urban or rural preponderance,overcrowding, aspirin intolerance, family history etc.
The results will be studies after calculating the odds ratio and the chi square test for whatever data is available. Interpretation will be performed subsequently.
Gene expression profiling would be performed to study the differences in gene expression levels between AC and EP s with respect to risk factors and morphological characteristics.Mutational analysis will be performed to identify mutations in selected genes.
|Study Type :||Observational|
|Estimated Enrollment :||180 participants|
|Observational Model:||Case Control|
|Official Title:||'The Factors Associated With the Formation of Nasal Polyp'|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||June 2013|
|Antrochaonal polyp; non recurrent type|
|Antrochoanal polyp; recurrent type|
|Ethmoidal polyp - non recurrent type|
|Ethmoidal polyp - recurrent type|
- Association of the antrochoanal and ethmoidal polyps with smoking, wood stove exposure, allergic rhinitis, deviated nasal septum, rhino sinusitis, non vegetarian diet,eosinophilia and staphylococcus aureus in terms of the odds ratio. [ Time Frame: 3 years ]Based on the questionnaire the patient will be evaluated for the presence of risk factors. Patient will be subjected to appropriate investigations like complete hemogram, absolute eosinophil count, contrast tomography scan of the paransal sinuses and serum IgE levels will be performed.An odds ratio will be calculated after taking appropriate controls in the ratio of 2:1.Significance levels will be calculated using Chi square test.
- Gene expression profiling of Antrochoanal and Ethmoidal nasal polyps [ Time Frame: 2yrs ]Three samples from each of the above three groups will be subjected to Microarray analysis. Differentially expressed genes will be selected and validation will be performed on 20 each of AC and EP groups.
- Mutational analysis of Antrochoanal and Ethmoidal nasal polyps [ Time Frame: 1year ]Once the genes have been identified based on Gene expression analysis, a few genes will be selected and studied for any possible mutations.
- Relationship of the nasal polyps with respect to the age, sex, religion, socioeconomic status, occupation, urban or rural preponderance, overcrowding and aspirin intolerance. [ Time Frame: 3 years ]A descriptive analysis will be performed to know the relationship of the antrochoanal and ethmoidal polyps with the above factors in terms of the percentages and will be analyzed appropriately.
- To study the cause for recurrence of Nasal polyps [ Time Frame: 3 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278719
|Contact: Dr. Manjunath D Narasaiah, MSfirstname.lastname@example.org|
|Contact: Dr. Vikram K Bhat, MS, PhD, DNBemail@example.com|
|Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences||Recruiting|
|Hubli, Karnataka, India, 580021|
|Contact: Dr.Manjunath D Narasaiah, MS +91-9900520748 firstname.lastname@example.org|
|Principal Investigator: Dr Manjunath Dandinarasaiah, MS|
|Principal Investigator:||Dr.Manjunath D Narasaiah, MS||Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India|