Clinical trial NCT01389401: Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis
Official title: Salivary Epidermal Growth Factor (EGF) Concentration Before and After Treatment of Reflux Laryngitis: Final Results
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease (GERD)
Chronic Laryngitis
Keywords: Larynx
GERD
saliva
epidermal growth factor
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 adults with reflux laryngitis 13 healthy controls

Brief summary: * 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

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 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

Primary outcomes:
measure: salivary EGF concentration
timeFrame: 120 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Otolaryngology Department of Santa Casa School of Medicine and Hospitals of São Paulo Brazil
Study officials:
affiliation: Assistant Professor Otolaryngology Department Santa Casa School of Medicine and Hospitals of São Paulo Brazil
name: CLAUDIA A ECKLEY, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.
citation: Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.
citation: Rourk RM, Namiot Z, Sarosiek J, Yu Z, McCallum RW. Impairment of salivary epidermal growth factor secretory response to esophageal mechanical and chemical stimulation in patients with reflux esophagitis. Am J Gastroenterol. 1994 Feb;89(2):237-44.
citation: Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.