MAST CELL STABILIZERS
- Mast cell stabilizers
- Cromolyn sodium (also referred to as cromoglycate and cromoglicate)
- Nedocromil (not available in the U.S.)
- Mast cell stabilizer
- Mast cells are cells found in connective tissues including the airways. Mast cells release histamine and other inflammatory substances in response to allergens. The process of releasing
inflammatory mediators by mast cells is referred to as "degranulation."
- Cromolyn inhibits mast cell degranulation thereby blocking the release of inflammatory mediators
- Asthma
- Prevention and prophylaxis in patients 2 years of age and older
- Exercise / allergen-induced asthma
- Cromolyn is indicated for the prevention of asthma that is triggered by exercise, exposure to cold air, and environmental agents (e.g., animal danders, toluene diisocyanate, pollutants)
- Overview
- Cromolyn sodium for inhalation is an older medication and there are a limited number of randomized controlled trials evaluating its efficacy
- A study comparing cromolyn to budesonide is summarized below
STUDY
Budesonide vs Cromolyn Sodium for Asthma in Young Children, Pediatrics (2002)
[PubMed abstract]
- Design: Randomized, controlled trial (N=335, length = 52 weeks)
- Treatment: Budesonide inhalation 0.5 mg daily vs Cromolyn nebulizer 20 mg four times daily
- Primary outcome: Rate of asthma exacerbations over 52 weeks
- Results:
- Primary outcome (asthma exacerbations per year): Budesonide - 1.23, Cromolyn - 2.41
- Findings: Budesonide inhalation suspension was more effective than nebulized cromolyn sodium in young children
with persistent asthma. Both treatments were well tolerated with similar adverse event profiles.
- Professional recommendations
- Summary
- In the U.S., cromolyn is only available to treat asthma as a nebulizer solution
- Cromolyn is dosed four times a day and is less effective than other therapies. For these reasons, it is rarely prescribed today.
- Overview
- Cromolyn sodium for inhalation is an older medication and there are a limited number of randomized controlled trials evaluating its efficacy
- A Cochrane meta-analysis from 2003 came to the conclusion that mast cell stabilizers provide a significant protective effect against exercise-induced bronchoconstriction
with few adverse effects. The same analysis concluded that SABAs are more effective than mast cell stabilizers, and mast cell stabilizers are more effective
than anticholinergic agents. [PMID 14583951 ]
- Professional recommendations
- General
- The incidence of side effects with cromolyn is not well-defined
- In general, cromolyn sodium is well-tolerated with minimal adverse reactions
- Side effects listed in the package insert include cough, nasal congestion, nausea, sneezing, and wheezing
- Paradoxical bronchospasm
- Paradoxical bronchospasm has been reported in some patients
- Hypersensitivity to cromolyn
- Kidney disease
- Has not been studied. Manufacturer makes no recommendation.
- Liver disease
- Has not been studied. Manufacturer makes no recommendation.
- No clinically relevant drug interactions have been identified
- Dosage form
- 2 ml vial
- Each 2 ml vial contains 20 mg of cromolyn sodium (10 mg/ml)
- Comes in carton with 60 vials
- Dosing
- Asthma (≥ 2 years old)
- One vial (20 mg) via nebulizer four times a day at regular intervals
- Exercise / allergen-induced asthma (≥ 2 years old)
- One vial (20 mg) via nebulizer shortly before exposure to the precipitating factor
- Storage / handling
- Store at room temperature
- Do not use if solution is discolored or contains a precipitate
- Protect from light
- Cost
- Cromolyn has been FDA-approved in the U.S since 1982. No long-term adverse effects have been identified.
- 1 - Cromolyn sodium PI
- 2 - PMID 14583951 - Mast-cell stabilising agents to prevent exercise-induced bronchoconstriction, Cochrane Database Syst Rev (2003)
