A Double-Blind Multicenter Group Comparative Study of the Efficacy and Safety of Nedocromil Sodium in the Management of Asthma: Methods (2)
Patients receiving immunotherapy remained at the same dose throughout. During the baseline and first two weeks of the treatment period, patients used their SRT and p* preparations. The SRT was then withdrawn. After six weeks on trial treatments, oral 02 wa$ withdrawn and inhaled p2 was to be used only when the study drug failed to control asthma symptoms. Immediate release theophylline preparations could be used if inhaled p2 did not provide relief. Medication use was scored is one point per unit dose theophylline, oral $8 tablet or for example, subcutaneous epinephrine or terbutaline and one point per two puff dose inhaled p2.
At a pre-baseline clinic visit, the reversibility of airway obstruction >15 percent improvement in FEV, after a p2 aerosol) was determined. Blood samples were taken for hematologic and biochemical tests, and urine samples for urinalysis.
The patients’ asthma was assessed by the clinician on a 0 to 5 scale (0 = none to 5 = severe), and daily diary cards were issued at the start of the baseline. Patients recorded the severity of nighttime asthma using a 0 to 2 scale (0 = slept well to 2 = awoke more than once because of asthma — Buy Asthma Inhalers Online), daytime asthma and cough using 0 to 5 scales (0 = none to 5 = severe), use of inhaled and oral broncho-dilators and the highest of three successive measurements of morning and evening PEFR, taken on arising and before retiring, respectively. The PEFR measurements were not to be taken within four hours of the use of a bronchodilator. During the treatment phase, patients recorded, in addition to the diary card variables, any unusual symptoms and their use of the trial treatments. At clinic visits (treatment weeks 0, 2, 6, 10 and 14), asthma severity was re-assessed and pulmonary function tests were performed.