Acute Effect of Sodium Cromoglycate on Airway Narrowing Induced by 4.5 Percent Saline Aerosol: Methods

Patients
Eleven patients with asthma (ten atopic), whose characteristics, lung function, and response to 4.5 percent saline aerosol are given in Table 1, attended the laboratory on five occasions. Eight of the 11 patients had never taken corticosteroid inhalants and three had not taken steroids within the last 2, 4, and 12 months. These patients were selected for study on the basis that they were about to be given corticosteroid inhalants for treatment of their asthma. Beta-2 adrenoceptor agonists and ipratropium bromide were withheld for 6 h before the study, theophylline and sodium cromoglycate were withheld for 24 h, and aerosol steroids were withheld on the morning of the study. The protocol had been approved by the Central Sydney Health Services Ethics Review Committee and consent was obtained in writing from each patient after explanation of the study was given.
Study Design
On the first visit to the laboratory, bronchial responsiveness to 4.5    percent saline aerosol was documented without premedication. On the second visit the 4.5 percent saline aerosol challenge was repeated 10 min after premedication with sodium cromoglycate. The patients were then immediately given budesonide by inhalation from a Turbuhaler in a dose of 1,000 mg/d. The patients took 600 p.g of budesonide in the morning and 400 fig in the evening every day. The patients returned to the laboratory after 24 to 54 days of treatment and repeated the 4.5 percent saline aerosol challenge. They returned to the laboratory on a fourth occasion within 2 to 10 days (average 4 days) and the challenge was repeated 10 min after sodium cromoglycate had been given by inhalation. Ten patients returned for a fifth challenge, after taking budesonide between 11 and 22 weeks. canadian health & care mall

Delivery of Sodium Cromoglycate
An ultrasonic nebulizer (Fisoneb, Fisons Corp, Rochester, NY) which produces an aerosol with a mass median aerodynamic diameter of 4.7 цт was used to deliver the sodium cromoglycate. Four milliliters containing 40 mg of sodium cromoglycate was placed in the nebulizer. The nebulizer was weighed before and after the patient inhaled the sodium cromoglycate, via a mouthpiece, for 5 min. The difference in the weight was used to estimate the amount of drug nebulized to the patient and this was 20.7 mg ±2.15. The 4.5 percent saline aerosol challenge commenced 10 min after the sodium cromoglycate had been given and after a measurement of FEV, had been made. Sodium cromoglycate did not change the baseline FEV,.

Table 1 — Anthropometric Details and Atopic Status of the Subjects

Sex Age,yr Ht,cm Atopyt PredFEV,,L FEV,,%Pred,Control PD20FEV,,mlControl Time Receiving Budesonide, wk
Visit 3 Visit 4 Visit 5
F 19 164 Y 3.02 78 1.11 5.0 5.3 15
F 17 155 Y 2.68 83 0.48 3.7 4.0 11.9
M 23 189 4.79 100 9.16 5.0 6.4 12.0
F 32 161 Y 2.71 83 0.87 4.9 5.3 11.1
M 41 182 Y 4.01 87 6.05 7.7 8.0 22.7
F 25 162 Y 2.86 84 1.58 4.7 5.0 11.1
M 27 179 Y 4.19 40 1.74 3.4 3.6 13.4
F 19 154 N 2.61 87 5.32 6.6 6.9 15.6
M 23 171 Y 3.88 58 16.3 5.0 5.3
F 18 158 Y 2.79 108 7.93 5.1 6.6 13.9
F 24 160 Y 2.79 111 1.47 4.6 5.3 13
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