Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CLAUDIA ALESSANDRA ECKLEY, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier:
NCT01389401
First received: July 6, 2011
Last updated: March 5, 2013
Last verified: March 2013
  Purpose
  • Saliva plays a key role in the homeostasis of the digestive tract
  • The reflux of gastroesophageal contents may cause damage to the esophageal, laryngeal and pharyngeal mucosas
  • There seems to be no correlation between the severity of reflux episodes and the intensity of inflammatory changes, suggesting individual protective mechanisms to refluxate exposure
  • Inorganic and Organic Salivary changes have been associated to Gastroesophageal Reflux Disease (GERD) and its supraesophageal manifestations, especially reflux laryngitis (Laryngopharyngeal Reflux- LPR)
  • Decreased salivary Epidermal Growth factor (EGF) concentrations have been found in patients with GERD and LPR, but it is unclear if these are primary or secondary to the disease.
  • Hypothesis: The decreased salivary EGF concentrations in patients with reflux laryngitis is primary and therefore would not change after treatment and control of the disease

Condition Intervention
Gastroesophageal Reflux Disease (GERD)
Chronic Laryngitis
Drug: omeprazole

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results

Resource links provided by NLM:


Further study details as provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:

Primary Outcome Measures:
  • salivary EGF concentration [ Time Frame: 120 days ] [ Designated as safety issue: No ]
    salivary Epidermal Growth Factor (EGF) concentrations were determined with commercially available ELISA kit from whole saliva sampled before and after treatment in study group and in healthy controls


Biospecimen Retention:   Samples Without DNA

whole saliva


Enrollment: 36
Study Start Date: January 2009
Study Completion Date: July 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
reflux laryngitis group pre-treatment
adults with clinical suspicion of Reflux Laryngitis confirmed by 24-hour double probe esophageal monitoring who have not made use of any treatment in the past 15 days.
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • reflux group pre-treatment
  • reflux group post-treatment
  • control group
study group - post treatment
adults with reflux laryngitis after 16 weeks of treatment with proton pump inhibitor (omeprazole 40 mg twice a day)and dietary/lifestyle changes that present improvement in symptoms and video laryngoscopic signs of chronic laryngitis
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • reflux group pre-treatment
  • reflux group post-treatment
  • control group
control group
healthy controls paired by gender and age that do not present symptoms and videolaryngoscopic signs suggestive of reflux laryngitis
Drug: omeprazole
omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
Other Names:
  • reflux group pre-treatment
  • reflux group post-treatment
  • control group

Detailed Description:

Background & Aims: Gastroesophageal Reflux Disease (GERD) is known to affect the upper airways and may cause a variety of inflammatory changes in the pharynx and larynx. The pathophysiology of the supraesophageal forms of GERD is widely unknown. Studies have suggested decreased salivary epidermal growth factor (EGF) concentrations in patients with reflux esophagitis and laryngitis. It is however unclear if these abnormalities are primary or secondary. The aim of the current cohort study was to compare salivary EGF concentrations in adults with reflux laryngitis before and after treatment and control of the disease to that of healthy individuals. Methods: Twenty-one patients with reflux laryngitis were studied prospectively at a tertiary teaching hospital. Spontaneous whole saliva was sampled before and after a 16-week course of full dose proton pump inhibitor (PPI) twice daily and compared to that of 13 healthy controls. Salivary EGF concentrations were established using a commercially available Elisa kit.

  Eligibility

Ages Eligible for Study:   19 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

25 adults with reflux laryngitis 13 healthy controls

Criteria

Inclusion Criteria:

  • study group:

    • symptoms of reflux laryngitis (Reflux Symptom Index- RSI >13) and videolaryngoscopic signs (Reflux Finding Score - RFS >7),
    • positive 24 hour double probe esophageal PH monitoring;
  • control group:

    • Reflux Symptom Index (RSI)<13
    • Reflux Finding Score (RFS) < 7

Exclusion Criteria:

  • tobacco, alcohol or other inhaled drug use;
  • chronic or acute rhinosinusitis;
  • prior history of surgery to the digestive tract or salivary glands;
  • prior or current diagnosis of head and neck or digestive tract tumors;
  • chronic use of drugs known to alter salivary flow and irritate the larynx, such as, diuretics, anticonvulsants, antihistamines, and inhaled steroids
  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: NCT01389401

Locations
Brazil
Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil
São Paulo, Brazil, 01222-000
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Investigators
Principal Investigator: CLAUDIA A ECKLEY, MD Assistant Professor Otolaryngology Department Santa Casa School of Medicine and Hospitals of São Paulo Brazil
  More Information

Publications:
Responsible Party: CLAUDIA ALESSANDRA ECKLEY, Claudia A. Eckley, MD, Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT01389401     History of Changes
Other Study ID Numbers: cescsp179/04
Study First Received: July 6, 2011
Last Updated: March 5, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
Larynx
GERD
saliva
epidermal growth factor

Additional relevant MeSH terms:
Gastroesophageal Reflux
Laryngitis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mitogens
Omeprazole
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Proton Pump Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014