The Factors Associated With the Formation of Nasal polyp-a Case Control and Descriptive Study

NCT01278719 | Unknown DMC

• 1 other identifier: KIMSPGS412
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Secondary Outcomes (2)

• Relationship of the nasal polyps with respect to the age, sex, religion, socioeconomic status, occupation, urban or rural preponderance, overcrowding and aspirin intolerance.

  3 years

• To study the cause for recurrence of Nasal polyps

  3 yrs

Study Arms (4)

Antrochaonal polyp; non recurrent type

Antrochoanal polyp; recurrent type

Ethmoidal polyp - non recurrent type

Ethmoidal polyp - recurrent type

Eligibility Criteria

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

You may qualify if:

• Antrochoanal and ethmoidal nasal polyps
• Recurrent nasal polyps
• Both infected and non infected polyps
• Both eosinophilic and non eosinophilic polyps

You may not qualify if:

• Exclusive neoplasms of nose and para nasal sinuses
• Immunodeficiency status like HIV

Sponsors & Collaborators

• Karnataka Institute of Medical Sciences: lead
• Ministry of Science and Technology, India: collaborator
• Applied Genetics: collaborator
• Lab Discoveries Ltd.: collaborator

Study Sites (1)

Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences

Hubli, Karnataka, 580021, India

RECRUITING

Related Publications (6)

• 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.

  PMID: 17275551 BACKGROUND

• 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.

  PMID: 10480701 RESULT

• 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.

  PMID: 12091997 RESULT

• 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.

  PMID: 12049564 RESULT

• Greisner WA 3rd, Settipane GA. Hereditary factor for nasal polyps. Allergy Asthma Proc. 1996 Sep-Oct;17(5):283-6. doi: 10.2500/108854196778662192.

  PMID: 8922148 RESULT

• 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.

  PMID: 833373 RESULT

MeSH Terms

Conditions

Nasal Polyps; Smoking; Rhinosinusitis; Rhinitis, Allergic; Recurrence

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior; Rhinitis; Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Dr.Manjunath D Narasaiah, MS

  Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Manjunath D Narasaiah, MS

CONTACT

+91-9900520748; drmanjud@gmail.com

Dr. Vikram K Bhat, MS, PhD, DNB

CONTACT

+91-9448658213; entvikram@rediffmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of ENT

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: January 19, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: April 23, 2012

Record last verified: 2012-04

Locations

IN (1)