Phase 3 N=75 Randomized Triple-blind Treatment

Efficacy of Lansoprazole in Chronic Post Nasal Drip

Larynx Disease

Bottom Line

View on ClinicalTrials.gov: NCT00335283 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: Post Nasal Drainage Symptom Response — 55; 3.5; 50; 5 Scores on a Scale — p=.01

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Lansoprazole Tablet (Drug); PH and impedence testing (Procedure); manometry (Procedure); lansoprazole (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Vanderbilt University
Primary completion: Dec 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Post Nasal Drainage Symptom Response	55; 3.5; 50; 5	.01 sig
SECONDARY Rhinosinusitis Outcome Measure(RSOM-31)	63; 51; 40; 36; 35; 35	.97
SECONDARY Sino Nasal Outcome Test (SNOT-20)	36; 35; 25; 32; 20; 27	.06
SECONDARY Quality of Life Questionnaire (QOLRAD)	155; 160; 174; 155; 173; 160	.006 sig

Summary

The purpose of this study is to determine whether aggressive acid suppression with Lansoprazole is effective in the treatment of post nasal drip, and also assess the predictors of response based on clinical and physiologic parameters.

Eligibility Criteria

Inclusion Criteria

Negative RAST inhalant allergy panel OR negative skin testing (Group A)
Positive RAST or Positive skin testing AND insufficient response to all of the following: (Group B)
Allergen avoidance
Topical nasal steroids
Allergy shots if indicated
Antihistamines
Negative CT sinuses (coronal)
< 4mm of mucosal thickening and < 3 sinus sites
Absence of air-fluid levels
Negative anterior rhinoscopy
Absence of pus, crusts on mucosal surfaces

Exclusion Criteria

Age < 18
Pregnancy, confirmed by urine pregnancy test at day of randomization
Ciliary dyskinesia
Immune deficiency
Cystic fibrosis
Diagnosis of acute sinusitis or chronic RS (AAO-HNS)
Active use of topical decongestant
Use of PPI within the last 30 days
Previous fundoplication
Uncontrolled thyroid disease
Isolated chronic cough without the symptom of post nasal drip

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00335283). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.