Trial record 19 of 39 for:    smoking [CONDITION] AND child [AGE-GROUP] | Open Studies

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Karnataka Institute of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministry of Science and Technology, India
Applied Genetics
Lab Discoveries Ltd.
Information provided by (Responsible Party):
Manjunath dandinarasaiah, Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01278719
First received: January 14, 2011
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

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
Nasal Polyp
Smoking
Rhinosinusitis
Allergic Rhinitis
Deviated Nasal Septum
ASA Intolerant Asthma

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 'The Factors Associated With the Formation of Nasal Polyp'

Resource links provided by NLM:


Further study details as provided by Karnataka Institute of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Once the genes have been identified based on Gene expression analysis, a few genes will be selected and studied for any possible mutations.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antrochaonal polyp; non recurrent type
Antrochoanal polyp; recurrent type
Ethmoidal polyp - non recurrent type
Ethmoidal polyp - recurrent type

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01278719

Contacts
Contact: Dr. Manjunath D Narasaiah, MS +91-9900520748 drmanjud@gmail.com
Contact: Dr. Vikram K Bhat, MS, PhD, DNB +91-9448658213 entvikram@rediffmail.com

Locations
India
Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences Recruiting
Hubli, Karnataka, India, 580021
Contact: Dr.Manjunath D Narasaiah, MS    +91-9900520748    drmanjud@gmail.com   
Principal Investigator: Dr Manjunath Dandinarasaiah, MS         
Sponsors and Collaborators
Karnataka Institute of Medical Sciences
Ministry of Science and Technology, India
Applied Genetics
Lab Discoveries Ltd.
Investigators
Principal Investigator: Dr.Manjunath D Narasaiah, MS Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India
  More Information

Publications:
Responsible Party: Manjunath dandinarasaiah, Department of ENT, Karnataka Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT01278719     History of Changes
Other Study ID Numbers: KIMSPGS412
Study First Received: January 14, 2011
Last Updated: April 20, 2012
Health Authority: India: Institutional research regulatory committee

Keywords provided by Karnataka Institute of Medical Sciences:
Antrochoanal polyp
Ethmoidal polyp
Recurrence
Risk factors
Environmental factors
Gene expression
Micro array
Mutation

Additional relevant MeSH terms:
Smoking
Nasal Polyps
Polyps
Rhinitis
Nose Deformities, Acquired
Sinusitis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical
Respiratory Tract Infections
Habits
Paranasal Sinus Diseases

ClinicalTrials.gov processed this record on July 23, 2014