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Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Pulmonary/Respiratory Diseases | Family Medicine

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Azmacort (triamcinolone acetonide) Inhalation Aerosol

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

Company: Rhone Poulenc Rorer
Approval Status: Approved November 1996
Treatment Area: asthma

General Information

Azmacort (triamcinolone acetonide) Inhalation Aerosol has been approved as a prophylactic therapy in the maintenance treatment of asthma with twice-daily dosing. Azmacort, the most widely prescribed inhaled bronchial steroid in the United States, was previously indicated for subjects who require chronic treatment for the control of bronchial asthma symptoms with a recommended dosage of two inhalations three to four times a day. The new prophylactic indication was received in conjunction with a recent class labeling change requested by the FDA.

The only inhaled anti-inflammatory with a built-in spacer--a device, which extends the space between the opening of the metered-dose inhaler (MDI) and the subject’s mouth--Azmacort is designed to enhance therapy and compliance. The National Institutes of Health (NIH) recommends use of spacers, as they may reduce the potential for side effects in the mouth and throat and minimize coordination problems between actuation and inhalation.

Clinical Results

The safety and efficacy of Azmacort given twice daily were demonstrated in two, six-week, placebo-controlled clinical trials involving 222 people with chronic asthma. Results of both studies demonstrated that treatment with Azmacort (400mcg twice daily) resulted in significant improvement in lung function and asthma symptoms such as wheezing and cough, as well as a decrease in bronchodilator use. Bronchodilators are medications commonly used to rescue asthma subjects once they feel an asthma attack is about to occur.

Side Effects

In clinical trials with Azmacort, the most commonly reported side effects were pharyngitis, hoarseness, dry and irritated throat, and dry mouth. As with all inhaled bronchial steroids, adrenal insufficiency may occur when transferring subjects from systemic steroids.

Additional Information

Asthma is a chronic inflammatory condition that affects 12 -15 million Americans--including 4.8 million children--and morbidity and mortality continue to rise. Asthma accounts for an estimated three million lost work days annually, and is the number one cause of absenteeism from school and hospitalization among children.