Smoking Clinical Trial
— ACAAGSONPOfficial title:
'The Factors Associated With the Formation of Nasal Polyp'
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.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | June 2013 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Antrochoanal and ethmoidal nasal polyps 2. Recurrent nasal polyps 3. Both infected and non infected polyps 4. Both eosinophilic and non eosinophilic polyps Exclusion Criteria: 1. Exclusive neoplasms of nose and para nasal sinuses 2. Immunodeficiency status like HIV |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
India | Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences | Hubli | Karnataka |
Lead Sponsor | Collaborator |
---|---|
Karnataka Institute of Medical Sciences | Applied Genetics, Lab Discoveries Ltd., Ministry of Science and Technology, India |
India,
Greisner WA 3rd, Settipane GA. Hereditary factor for nasal polyps. Allergy Asthma Proc. 1996 Sep-Oct;17(5):283-6. — View Citation
Hedman J, Kaprio J, Poussa T, Nieminen MM. Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study. Int J Epidemiol. 1999 Aug;28(4):717-22. — View Citation
Kim J, Hanley JA. The role of woodstoves in the etiology of nasal polyposis. Arch Otolaryngol Head Neck Surg. 2002 Jun;128(6):682-6. — View Citation
Rugina M, Serrano E, Klossek JM, Crampette L, Stoll D, Bebear JP, Perrahia M, Rouvier P, Peynegre R. Epidemiological and clinical aspects of nasal polyposis in France; the ORLI group experience. Rhinology. 2002 Jun;40(2):75-9. — View Citation
Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21. — View Citation
Videler WJ, van Drunen CM, van der Meulen FW, Fokkens WJ. Radical surgery: effect on quality of life and pain in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Feb;136(2):261-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 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. | 3 years | Yes |
Primary | Gene expression profiling of Antrochoanal and Ethmoidal nasal polyps | 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. | 2yrs | Yes |
Primary | Mutational analysis of Antrochoanal and Ethmoidal nasal polyps | Once the genes have been identified based on Gene expression analysis, a few genes will be selected and studied for any possible mutations. | 1year | Yes |
Secondary | Relationship of the nasal polyps with respect to the age, sex, religion, socioeconomic status, occupation, urban or rural preponderance, overcrowding and aspirin intolerance. | 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. | 3 years | Yes |
Secondary | To study the cause for recurrence of Nasal polyps | 3 yrs | Yes |
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