As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma

Phase 3 Completed 480 enrolled Chiesi Farmaceutici S.p.A.

RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of this study is to reveal that inhaled corticosteroid therapy combined with a short-acting beta2- agonist given on a symptom driven basis is as effective as traditional asthma therapy. Thus, three advantages will be achieved: 1. better compliance with treatment since patients will most likely have to administer the treatment less frequently, 2. maximum pharmacological effect with the least amount of drug and 3. less economic burden on health care providers.

Timeline

Start: 2002-08
Primary completion: —
Completion: 2004-09

Outcome

Met primary endpoint

paper the morning peak expiratory flow rate during the last 2 weeks of the 6-month treatment was higher (P=0.04) PMID 17507703 ↗

paper in the as-needed combination therapy group than in the as-needed albuterol therapy group PMID 17507703 ↗

Publications

Results Papi A, Canonica GW, Maestrelli P, Paggiaro P, Olivieri D, Pozzi E, Crimi N, Vignola AM, Morelli P, Nicolini G, Fabbri LM; BEST Study Group. Rescue use of beclomethasone and albuterol in a single inhaler for mild asthma. N Engl J Med. 2007 May 17;356(20):2040-52. doi: 10.1056/NEJMoa063861.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Beclomethasone	Small molecule	250 ug	Inhaled
Subject	Salbutamol	Unknown	100 ug	Inhaled