Clinical trial NCT01278719: The Factors Associated With the Formation of Nasal polyp-a Case Control and Descriptive Study
Official title: 'The Factors Associated With the Formation of Nasal Polyp'
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal Polyp
Smoking
Rhinosinusitis
Allergic Rhinitis
Deviated Nasal Septum
ASA Intolerant Asthma
Keywords: Antrochoanal polyp
Ethmoidal polyp
Recurrence
Risk factors
Environmental factors
Gene expression
Micro array
Mutation
Lead sponsor: Karnataka Institute of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, India
name: Applied Genetics
name: Lab Discoveries Ltd.
First posted: 2011-01-19
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with nasal polyps attending Otorhinolaryngology outpatient department at the Karnataka institute of medical sciences, Hubli which is a tertiary care hospital situated in the north of Karnataka state in India.The hospital caters to all socioeconomic strata with vast diversities.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 3 years
measure: Gene expression profiling of Antrochoanal and Ethmoidal nasal polyps
timeFrame: 2yrs
measure: Mutational analysis of Antrochoanal and Ethmoidal nasal polyps
timeFrame: 1year
Secondary outcomes:
measure: Relationship of the nasal polyps with respect to the age, sex, religion, socioeconomic status, occupation, urban or rural preponderance, overcrowding and aspirin intolerance.
timeFrame: 3 years
measure: To study the cause for recurrence of Nasal polyps
timeFrame: 3 yrs
Other outcomes:
Locations:
city: Hubli
country: India
facility: Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences
state: Karnataka
Study officials:
affiliation: Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India
name: Dr.Manjunath D Narasaiah, MS
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/j.otohns.2006.08.010.
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. doi: 10.1093/ije/28.4.717.
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.
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. doi: 10.1001/archotol.128.6.682.
citation: Greisner WA 3rd, Settipane GA. Hereditary factor for nasal polyps. Allergy Asthma Proc. 1996 Sep-Oct;17(5):283-6. doi: 10.2500/108854196778662192.
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. doi: 10.1016/0091-6749(77)90171-3.