PMID- 14512676
OWN - NLM
STAT- MEDLINE
DCOM- 20040120
LR  - 20171101
IS  - 0025-7931 (Print)
IS  - 0025-7931 (Linking)
VI  - 70
IP  - 4
DP  - 2003 Jul-Aug
TI  - Efficacy, safety, and acceptance of beclomethasone dipropionate administered via 
      a new dry powder Inhaler or a standard CFC metered-dose inhaler in asthma 
      patients.
PG  - 399-406
AB  - BACKGROUND/OBJECTIVES: The mechanical aerosol generator, MAGhaler, is a new 
      chlorofluorocarbon-free inhalation device. The objective of this trial was to 
      show equivalent efficacy and safety of beclomethasone dipropionate (BDP) 
      delivered via the MAGhaler and the metered-dose inhaler (MDI) in patients with 
      mild to moderate bronchial asthma. Moreover, user-friendliness and acceptance of 
      the two devices were compared. METHODS: This was a double-blind, 
      reference-controlled, 12-week trial in 171 patients with asthma receiving BDP 
      (1,000 microg/day) delivered via either the MAGhaler or the conventional MDI. 
      Respiratory function parameters, clinical symptoms, concomitant intake of 
      salbutamol or fenoterol, adverse events (AEs), laboratory values, and concomitant 
      medications and diseases were recorded. The primary efficacy parameter was mean 
      forced expiratory volume in 1 s (FEV1), measured after 4, 8, and 12 weeks of 
      therapy. RESULTS: The equivalence of the two devices was confirmed (p = 0.003) on 
      the basis of the ratios of the mean FEV1 in weeks 4 to 12. Mean (+/- SD) FEV1 
      (MAGhaler was 2.24 +/- 0.60 l (baseline), 2.61 +/- 0.90 litres (week 4), and 2.62 
      +/- 0.87 litres (weeks 4-12). Mean FEV1 (MDI) was 2.28 +/- 0.59 litres 
      (baseline), 2.53 +/- 0.82 litres (week 4), and 2.56 +/- 0.77 litres (weeks 4-12). 
      In total, 33 AEs occurred in 26 (30.2%) patients (MAGhaler) and 51 AEs in 36 
      (42.4%) patients (MDI). Most of the AEs were of mild or moderate intensity. The 
      relationship to treatment could not be excluded for 11 AEs in 11 patients 
      (MAGhaler) and 23 AEs in 18 patients (MDI). Three serious AEs, all unrelated to 
      treatment, occurred in 3 patients (MAGhaler: 2, MDI: 1). There were no clinically 
      relevant changes in other safety parameters. Most patients either preferred the 
      MAGhaler or rated the two devices as equally acceptable. CONCLUSION: The new 
      MAGhaler was equivalent to the standard MDI in terms of the safety and efficacy 
      of BDP. The improved user-friendliness and acceptance of the MAGhaler over the 
      conventional MDI represent an important advance in the clinical management of 
      bronchial asthma.
CI  - Copyright 2003 S. Karger AG, Basel
FAU - Kunkel, G
AU  - Kunkel G
AD  - Allergy and Asthma Clinic, Humboldt University Charite, Virchow-Klinikum, Berlin, 
      Germany. petra.blank@charite.de
FAU - Schaper, C
AU  - Schaper C
FAU - Noga, O
AU  - Noga O
FAU - Schlafke, S
AU  - Schlafke S
FAU - Lemmnitz, G
AU  - Lemmnitz G
FAU - Kohler, S
AU  - Kohler S
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - Respiration
JT  - Respiration; international review of thoracic diseases
JID - 0137356
RN  - 0 (Anti-Asthmatic Agents)
RN  - 0 (Powders)
RN  - KGZ1SLC28Z (Beclomethasone)
SB  - IM
MH  - Adult
MH  - Anti-Asthmatic Agents/*administration & dosage/adverse effects
MH  - Asthma/*drug therapy/physiopathology
MH  - Beclomethasone/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume
MH  - Humans
MH  - Male
MH  - Metered Dose Inhalers
MH  - Middle Aged
MH  - Nebulizers and Vaporizers
MH  - Patient Acceptance of Health Care
MH  - Patient Compliance
MH  - Patient Satisfaction
MH  - Powders
MH  - Respiratory Function Tests
MH  - Therapeutic Equivalency
MH  - Treatment Outcome
EDAT- 2003/09/27 05:00
MHDA- 2004/01/21 05:00
CRDT- 2003/09/27 05:00
PHST- 2001/05/31 00:00 [received]
PHST- 2003/05/15 00:00 [accepted]
PHST- 2003/09/27 05:00 [pubmed]
PHST- 2004/01/21 05:00 [medline]
PHST- 2003/09/27 05:00 [entrez]
AID - 72904 [pii]
AID - 10.1159/000072904 [doi]
PST - ppublish
SO  - Respiration. 2003 Jul-Aug;70(4):399-406. doi: 10.1159/000072904.