Comparison of Respiratory Effects of Two Cardioselective Beta-Blockers, Celiprolol and Atenolol, in Asthmatics: Trial Procedure

In: Asthma

6 Oct 2014

Trial Procedure
After a single-blind two-week placebo run-in period, the patients were randomly given in a double-blind manner either 100 mg atenolol or 400 mg celiprolol daily for four weeks. Thereafter, all patients completed a two-week placebo crossover period and then received the alternative beta-blocker daily for a further four-week period (Fig 1).
Patients were seen every two weeks. At each visit, blood pressure with the patient in the supine and erect positions and pulse rates were recorded 24 h after the last dose of study medication. All blood pressure readings were made on the right arm, between 0800 and 0900, and after at least 5 min of seated rest. Readings were repeated after the patient was at least 1 min in the supine or erect position. Disappearance of Korotkoff 5 sounds was the diastolic pressure, and the mean of three consecutive readings was taken for each measurement.A single-dose challenge was then performed as follows: first, the best of three consecutive predose pulmonary function tests (FVC and FEV, measured on a Vitalograph and PEF measured with a mini-Wright peak flow meter) were obtained by a trained respiratory technologist. A single oral dose (placebo, 100 mg atenolol or 400 mg celiprolol) was then administered and respiratory function tests were repeated after 30 min, 1, 2 and 3 hours. At 3 h, a 200-p.g dose of inhaled salbutamol was administered, and spirometry was performed after 5 and 15 min.
During each phase of the study, including the run-in period, patients recorded the following on diary cards: fully

1. Symptom scores of cough and dyspnea during the preceding 12 h (twice daily recordings). Cough was scored as follows: (a) no cough, (b) occasional cough, (c) bad cough— intermittently, (d) bad cough most of the time. Dyspnea was scored as follows: (a) did not wake up at night, (b) awoke one to three times but slept between, (c) awoke four to six times but slept between, (d) awoke more than six times.
2. Inhaler use over the preceding 12 h (twice daily).
3. Morning and evening peak flow measurements. Each patient was trained to use a mini-Wright peak flow meter and to record each of three attempts.
4. Time of daily medication intake.

Figure 1. Trial design.

Figure 1. Trial design.

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