The effect of inhaled and intranasal sodium cromoglycate on symptoms of upper respiratory tract infections.

Background: A well established drug for the treatment of asthma and allergy, sodium cromoglycate, was found in open trials to be useful as a symptomatic treatment for upper respiratory tract infections.

Objective: To compare the efficacy of inhaled and intranasal sodium cromoglycate and matching placebos on the symptoms of upper respiratory tract infections.

Methods: Adult subjects with symptoms of runny nose, throat pain, or cough for less than 24 h were recruited. They were treated for 7 days using a randomized, double-blind, placebo-controlled, group comparative design. The medication given was: sodium cromoglycate dry powder 20 mg per inhalation in spincaps; sodium cromoglycate aqueous nasal spray delivering 5.2 mg per dose; or matching placebo as dry powder and nasal spray. One spincap and one spray per nostril were taken every 2 h during waking hours on days 1 and 2 and then four times daily on days 3-7. Severity of nine symptoms (general malaise, body aches and pains, chills and shivering, sneezing, nasal running, nasal blocking, sore throat, cough and voice disturbance) was recorded twice daily by subjects on diary cards, using a scale of 0 (absent) to 3 (severe).

Results: The study was conducted between February and April 1993. One hundred and eighteen patients aged 21-63 years (mean 41 years) were included. Symptoms resolved faster (P < 0.001) and the severity in the last three days of treatment was significantly less in patients treated with sodium cromoglycate than with placebo (P < 0.05-day 5; P < 0.01-day 6; P < 0.001-day 7). Side effects were local and mild and did not differ between the treatment groups.

Conclusion: Sodium cromoglycate administered both by inhalation and intranasally is an effective treatment for the symptoms of upper respiratory tract infection. Its combined safety and efficacy would make it an acceptable form of treatment for these conditions.