Study design (if review, criteria of inclusion for studies)
3-way cross-over trial over 3 days
Participants
20 participants (7 males), age range 13 - 36 years NIH score 43 - 85
Interventions
Day 1: 2 puffs of albuterol MDI (180 mcg prior to 4 sessions of CPT) Day 2: 2 puffs of salmeterol (42 mcg) before first and last sessions of CPT and placebo before sessions 2 and 3 Day 3: 2 puffs of placebo. CPT sessions at 0700 hours, 1100 hours, 1500 hours and 2100 hours
Outcome measures
Changes in spirometry (FEV1, FVC, FEF25-75 )measured pre- and 45 minutes post 0700 hours and 1500 hours, pre- 1900 hours and pre- 0700 hours next morning.
Main results
Eighteen patients in the low-dose group and 10 of the same 18 patients in the high-dose group completed the 3 consecutive days of testing and received either salmeterol, albuterol, or placebo with each of four chest physiotherapy sessions given at 7 AM, 11 AM, 3 PM, and 7 PM. At standard doses (2 puffs), the mean percent changes in FEV1 pre- to post-7 AM therapy for salmeterol (5.5%) and albuterol (9.9%) were significantly greater than with placebo (-1.2%) (P < 0.05 and 0.01, respectively). The mean percent changes in FEV1 from morning baseline with salmeterol were also significantly greater than placebo before 3 PM (12.1% vs. 5.4%, P < 0.01), and neither albuterol nor salmeterol were significantly greater than placebo after 3 PM. At standard doses there was a significant carryover effect with salmeterol to the next morning for the FEV1 (7.3%) when compared to placebo (1.5%) and albuterol (-0.7%) (P < 0.05 and 0.05, respectively). At high doses (4 puffs), the mean percent change in FEV1 with pre- to post-7 AM therapy increased to 22.7% and remained significantly greater than with placebo until pretherapy at 7 PM. The carryover effect the next morning was 14.7%. Salmeterol at 4 puffs compared favorably to albuterol nebulizer therapy given TID in both the incidence of responders for the FEV1 (70% vs. 71%) and the mean changes after therapy at 7 AM (22.7% vs. 14.9%), and provided greater carryover effects to the next morning (14.7% vs. -0.7%), thus preventing the fall in pulmonary function back to baseline overnight.
Authors' conclusions
We recommend the use of high-dose salmeterol in hospitalized patients with FVC values of 40% of predicted or greater, starting with 2 and increasing to 4 puffs BID as tolerated.
Keywords: Adolescent; Adrenergic beta-Agonists; Adult; Albuterol; Artificial Ventilation; Bronchodilator Agents; Hospitalization; Hospital care; Inhalation OR nebulised; non pharmacological intervention - devices OR physiotherapy; non pharmacological intervention - psyco-soc-edu-org; pharmacological_intervention; salmeterol; Ventilators; High-Dose; Respiratory System Agents; Organization;