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Clinical Trials

NasalCrom Nasal Spray

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved April 2001

Specific Treatments:

Allergic Rhinitis

General Information

NasalCrom Nasal Spray has been approved for the treatment of nasal allergy symptoms, for use in children ages two to five years. It is the only treatment indicated for all nasal allergy symptoms that is available over-the-counter (OTC). For best results, this medication should be taken for one full week before coming in contact with allergens and should then be taken three to four times daily.

NasalCrom was first introduced, in 1983, as a prescription medication for adults. In 1997 it became available OTC for adults as well as children ages six and older. Unilke other OTC allergy treatments, NasalCrom does not produce unwanted side effects, such as drowsiness or jitteriness.

It is estimated that nearly 40 percent of children under the age of six have allergic rhinitis and that this condition causes more than 800,000 missed school days in older children.

Clinical Results

NasalCrom was evaluated as a treatment for nasal allergy symptoms in a multi-center, multi-dose, randomized, double-blind study of 200 children, ages two to six years, who suffer from allergic rhinitis. Results showed that NasalCrom, after one week of treatment, was more effective than placebo in alleviating nasal allergy symptoms. The drug was well tolerated and demonstrated a side effect profile similar to placebo.

Side Effects

Adverse events associated with the use of cromolyn sodium may include (but are not limited to) the following:

  • Irritation inside of nose
  • Flushing
  • Increase in sneezing

Mechanism of Action

NasalCrom Nasal Spray (cromolyn sodium) works as a mast-cell stabilizer, blocking cells in the body from releasing substances that cause the bronchial tubes to tighten and constrict. Normally, upon entering the nose, an allergen triggers the mast cells that line the nasal passages to break down and release histamines, which cause nasal allergy symptoms. NasalCrom provides a protective layer that shields mast cells from these allergens.

Additional Information

For additional information on NasalCrom, please visit Pharmacia.

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