Randomized Clinical Trials to Compare Asthma Control Efficacy of the Fine-particle Combination Formoterol/Beclomethasone by pMDI Administered With and Without Spacer. (EFFECT-EV)

NCT01453881 Phase 3 COMPLETED

Adequate pharmacological treatment controls symptoms in most asthmatics. Pressurized metered dose inhalers (pMDI)are the most used drug delivery devices. Valved holding chambers of different types and sizes have also been developed for use in combination with pMDI. The therapeutic efficacy of treatment depends on the amount of inhaled particles. The chambers can optimize lung deposition as it obviates lung-hand coordination and retain larger particles. The aim of this study is to compare the efficacy of the fine particle combination pMDI Beclomethasone/Formoterol in asthma control,with or without the aid of a spacer in patients without adequate asthma control on medium to high-dose inhaled steroids associated with long acting beta adrenergic drugs. The hypothesis is that there is no clinical efficacy difference between the two forms of drug administration.

Details

Lead sponsor	Universidade Federal de Pernambuco
Phase	Phase 3
Status	COMPLETED
Enrolment	45
Start date	2011-04
Completion	2013-06

Conditions

• Asthma

Interventions

• Spacer
• Comparator

Primary outcomes

• Change in Asthma Control Test Score — 8 weeks
  The primary endpoint is the difference in the change of ACT score between groups 8 weeks after randomization compared to pre-randomization.

Countries

Brazil