Public Assessment Report for paediatric studies submitted in ...

total number and 10% out of clinic) or placebo (13% total number and 9% out of clinic). The incidence of
patients having two or more exacerbations was very low and comparable among treatment groups (2-4%).
Conclusions:
Albuterol DISKUS and albuterol MDI significantly improve bronchodilation compared to
placebo in paediatric patients aged 4-11 years with asthma.
Albuterol DISKUS and albuterol MDI are well tolerated and show comparable safety to placebo
throughout a 4-week treatment period in paediatric patients aged 4-11 years with asthma.
Albuterol DISKUS and albuterol MDI produce comparable improvements in lung function in
paediatric patients.
In the responder subset, albuterol DISKUS and albuterol MDI produce clinically significant
onset of improvement (≥15% over baseline) in pulmonary function between 3 to 4 minutes after dosing
and maintain this improvement for 2-4 hours.
Study Code: SALA2003
Study Title: A Randomized, Double-blind, Double-Dummy, Single-Dose, Six-Way
Crossover Study to Compare the Safety and Efficacy of Single Dose of 200 and 400 mcg Albuterol
Powder Via DISKUS With Single Dose of 100, 200 and 400 mcg (90, 180 and 360 mcg Ex-Actuator)
Albuterol Aerosol Via MDI and Placebo in Subjects, Aged 4-11 Years, With Asthma.
Study period: 08 Mar 1997 – 12 Aug 1997.
GSK Study Report Number: Report Nos. RM1998/0055/00.
Methods
Protocol SALA2003 was designed to assess the safety and efficacy of both 200 and 400 mcg
doses of albuterol powder via DISKUS, as well as comparability with 100, 200 and 400 mcg doses of
albuterol via MDI and placebo in asthma patients, 4 to 11 years of age.
• Objective
1. to compare the safety and efficacy of single doses of 200 and 400 mcg albuterol powder via
DISKUS with single doses of 100, 200 and 400 mcg (90, 180 and 360 mcg ex-actuator) albuterol aerosol
via MDI and placebo in paediatric patients (ages 4-11 years) with asthma;
2. to demonstrate dose-response characteristics of both albuterol formulations.
• Study design
Multicenter, Randomized, Double-blind, Double-Dummy, single-dose, placebo-controlled, sixway
crossover, multicenter in paediatric patients with asthma.
The study included a screening visit conducted 3-14 days before the Treatment Visit 1, followed
by six treatment visits, each separated by 1-14 days.
This study included a concurrent placebo treatment with an additional active control comparator
treatment (MDI). The study drug was supplied in identical MDI devices and identical DISKUS devices in
blind treatments.
Phase II.
Location: 5 centers in the Unites States.
The clinical trial, including study medication management, was monitored by Glaxo Wellcome
personnel with one contract monitor from Research Scientists, Inc (Los Angeles, CA). Site visits were
scheduled every 4 to 8 weeks depending on site enrollment. Covance, Inc (Indianapolis, IN) was the
Salbutamol Final Public Assessment Report
RO/W/0001/pdWS/001
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