Comparison of a short course of prednisolone with sustained-release theophylline in the control of nocturnal asthma.

Nocturnal asthma is now considered to be a manifestation of increased bronchial inflammation and responsiveness at night. Inhaled steroids have been shown to be effective in its control. However, the role of oral steroids has not been defined. A double blind, randomised, parallel-group, double-dummy study was carried out to evaluate the role of oral prednisolone in the management of nocturnal asthma and compare it with the more often used sustained-release theophylline. Twenty chronic perennial asthmatics with complaints of at least 3 awakenings at night due to asthmatic symptoms during the preceding week were included in the study and divided randomly into two groups of 10 each. Group A patients were put on a single, morning (8 AM) 30mg (6 x 5mg) dose of prednisolone plus placebo tablets b.i.d. (10 AM & 10 PM) while Group B patients received sustained-release theophylline (600-800mg per day) in b.i.d. dosage (10 AM & 10 PM) plus 6 placebo tablets in the morning (8 AM). The treatments were continued for 1 week. The evaluation parameters included nocturnal awakenings, additional inhalations of salbutamol, daytime asthma scores and spirometry. Both the treatments effectively controlled nocturnal asthma. However, relief was quicker in Group A and associated with a better daytime control and a greater improvement in lung function. In Group A, the mean daily nocturnal asthma score fell from 0.58 +/- 0.14 during the pretreatment week (run-in) to 0.10 +/- 0.09 during the treatment (P<0.001), the additional drugs score fell from 1.34 +/- 0.42 to 0.16 +/- 0.13 (P<0.001), FVC increased from 75.3 +/- 19.4 to 83.9 +/- 12.5% predicted (P<0.002) and FEV1 increased from 41 +/- 10.7 to 63.7 +/- 14.3% predicted (P<0.001). In Group B, the mean nocturnal asthma score fell from 0.63 +/- .0.19 to 0.26 +/- 0.15 (P<0.001) and the additional drugs score fell from 1.34 +/- 0.44 to 0.44 +/- 0.28 (P<0.001). The increase in FVC from 73.9 +/- 18.9 to 74.9 +/- 14.2% predicted was not significant (P>0.05) while the FEV1 increased from 39.8 +/- 9.4 to 48.2 +/- 8.04% predicted (P<0.001). The mean daily daytime asthma score in Group A during the treatment was 0.41 +/- 0.17 which was significantly (P<0.001) lower than in Group B where it was 1.41 +/- 0.34. It was concluded that while both the drugs are effective, a short course of a moderately high dose of oral prednisolone is superior to sustained-release theophylline in controlling nocturnal asthma.

RCT Entities:   Population Interventions Outcomes