Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis

University of Tennessee

Status and phase: Completed; Phase 4

Conditions: Eosinophilic Esophagitis

Treatments: Drug: Placebo; Drug: oral cromolyn sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02371941

13-02521-FB

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study of oral cromolyn sodium when made into a viscous preparation for the treatment of eosinophilic esophagitis.

Full description

Eosinophilic esophagitis is an antigen-mediated allergic disease of the esophagus characterized by symptoms of gastrointestinal complaints and eosinophilic inflammation limited to the esophagus. Currently, first line therapeutic recommendations include swallowed, topical steroids or dietary therapy. While both work for the majority of patients, they both have limitations.

The investigators are examining the use of oral cromolyn sodium as a treatment for this condition. This medication is a non-steroid that is already approved for other conditions. When taken orally, it is essentially not absorbed systemically, so side effects are minimal. There is only 1 brief, retrospective report of its use in this condition suggesting it does not work. However, from studying swallowed, topical steroids, it may require formulating the medication into a viscous preparation for it to work.

Enrollment: 16 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of eosinophilic esophagitis

Exclusion criteria

• Concomitant treatment with swallowed corticosteroids. Any prior use of swallowed corticosteroids will require a 4 week washout period.
• Pregnancy (all females of child bearing potential will have urine pregnancy test done at baseline).
• Evidence of pathologic eosinophilia in other locations in the GI tract.
• Participation in another research protocol
• Reduced Renal or Hepatic Function (all subjects will have a baseline creatinine and liver function panel drawn)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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16 participants in 2 patient groups, including a placebo group

Oral cromolyn

Experimental group

Description:

Subjects randomized to the experimental arm will receive oral cromolyn sodium. The dose will be per current package insert for oral cromolyn: Subjects 2-12 years of age - 100 mg (1 ampule) 4 times daily Subjects 13-18 years of age - 200 mg (2 ampules) 4 times daily

Treatment:

Drug: oral cromolyn sodium

Placebo

Placebo Comparator group

Description:

Subjects randomized to placebo will receive normal saline ampules Subjects 2-12 years of age - 1 ampule 4 times daily Subjects 13-18 years of age - 2 ampules 4 times daily

Treatment:

Drug: Placebo