Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate

E. F. Juniper, David Brendan Price, P. A. Stampone, J. P. H. M. Creemers, S. J. M. Mol, P. Fireman

Research output: Contribution to journalArticle

106 Citations (Scopus)

Abstract

Study objective: Clinical trials of asthma treatments usually use measures of asthma control to assess efficacy. However, it is also important to determine whether patients themselves benefit from interventions. The aim of this study was to evaluate health-related quality of life in patients with asthma switched from conventional chlorofluorocarbon (CFC) beclomethasone dipropionate (BDP) to hydrofluroalkane-134a (HFA) BDP extrafine aerosol at half the daily dose.

Design: Open-label, 12-month, parallel-group, randomized trial. Setting: Fifty-seven centers in four countries (United States, Belgium, the Netherlands, and United Kingdom).

Patients: Four hundred seventy-three patients with a greater than or equal to 6-month history of asthma, stable symptoms, and maintained on CFC-BDP, 400 to 1,600 mug/d.

Interventions: HFA-BDP, 200 to 800 mug/d (n = 354), or CFC-BDP, 400 to 1,600 mug/d (n = 119).

Measurements and results: The Asthma Quality of Life Questionnaire (AQLQ) and pulmonary function tests were completed at months 0, 2, 4, 8, and 12. For 1 month before each visit, patients made daily recordings of symptoms, peak expiratory flow, and beta(2)-agonist use. Two hundred ninety-six patients completed the study (HFA-BDP, 83.6%; CFC-BDP, 83.2%). At month 12, improvements in overall AQLQ scores were greater in the HFA-BDP group than in the CFC-BDP group (p = 0.0024). The number of patients who need to be treated with HFA-BDP for one to have a clinically important improvement in overall asthma-specific quality of life compared with CFC-BDP was 7.3. There was no evidence of differences (p > 0.05) between treatment groups for airway caliber, symptoms, or beta(2)-agonist use.

Conclusion: Clinically important improvements in the AQLQ score were observed at month 12 for HFA-BDP vs CFC-BDP, while conventional clinical indexes of pulmonary function and asthma control were similar in the two groups.

Original languageEnglish
Pages (from-to)1824-1832
Number of pages8
JournalChest
Volume121
Issue number6
DOIs
Publication statusPublished - Jun 2002

Keywords

  • asthma
  • beclomethasone dipropionate
  • chlorofluorocarbon
  • clinical trial
  • hydrofluoroalkane-134a
  • inhaled corticosteroids
  • metered-dose inhaler
  • quality of life
  • 400 MU-G
  • OF-LIFE
  • MODERATE ASTHMA
  • TRIALS
  • QUESTIONNAIRE
  • EFFICACY
  • AEROSOL

Cite this

@article{39cd00b23b8c424689a701e994ac9770,
title = "Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate",
abstract = "Study objective: Clinical trials of asthma treatments usually use measures of asthma control to assess efficacy. However, it is also important to determine whether patients themselves benefit from interventions. The aim of this study was to evaluate health-related quality of life in patients with asthma switched from conventional chlorofluorocarbon (CFC) beclomethasone dipropionate (BDP) to hydrofluroalkane-134a (HFA) BDP extrafine aerosol at half the daily dose.Design: Open-label, 12-month, parallel-group, randomized trial. Setting: Fifty-seven centers in four countries (United States, Belgium, the Netherlands, and United Kingdom).Patients: Four hundred seventy-three patients with a greater than or equal to 6-month history of asthma, stable symptoms, and maintained on CFC-BDP, 400 to 1,600 mug/d.Interventions: HFA-BDP, 200 to 800 mug/d (n = 354), or CFC-BDP, 400 to 1,600 mug/d (n = 119).Measurements and results: The Asthma Quality of Life Questionnaire (AQLQ) and pulmonary function tests were completed at months 0, 2, 4, 8, and 12. For 1 month before each visit, patients made daily recordings of symptoms, peak expiratory flow, and beta(2)-agonist use. Two hundred ninety-six patients completed the study (HFA-BDP, 83.6{\%}; CFC-BDP, 83.2{\%}). At month 12, improvements in overall AQLQ scores were greater in the HFA-BDP group than in the CFC-BDP group (p = 0.0024). The number of patients who need to be treated with HFA-BDP for one to have a clinically important improvement in overall asthma-specific quality of life compared with CFC-BDP was 7.3. There was no evidence of differences (p > 0.05) between treatment groups for airway caliber, symptoms, or beta(2)-agonist use.Conclusion: Clinically important improvements in the AQLQ score were observed at month 12 for HFA-BDP vs CFC-BDP, while conventional clinical indexes of pulmonary function and asthma control were similar in the two groups.",
keywords = "asthma, beclomethasone dipropionate, chlorofluorocarbon, clinical trial, hydrofluoroalkane-134a, inhaled corticosteroids, metered-dose inhaler, quality of life, 400 MU-G, OF-LIFE, MODERATE ASTHMA, TRIALS, QUESTIONNAIRE, EFFICACY, AEROSOL",
author = "Juniper, {E. F.} and Price, {David Brendan} and Stampone, {P. A.} and Creemers, {J. P. H. M.} and Mol, {S. J. M.} and P. Fireman",
year = "2002",
month = "6",
doi = "10.1378/chest.121.6.1824",
language = "English",
volume = "121",
pages = "1824--1832",
journal = "Chest",
issn = "0012-3692",
publisher = "American College of Chest Physicians",
number = "6",

}

TY - JOUR

T1 - Clinically important improvements in asthma-specific quality of life, but no difference in conventional clinical indexes in patients changed from conventional beclomethasone dipropionate to approximately half the dose of extrafine beclomethasone dipropionate

AU - Juniper, E. F.

AU - Price, David Brendan

AU - Stampone, P. A.

AU - Creemers, J. P. H. M.

AU - Mol, S. J. M.

AU - Fireman, P.

PY - 2002/6

Y1 - 2002/6

N2 - Study objective: Clinical trials of asthma treatments usually use measures of asthma control to assess efficacy. However, it is also important to determine whether patients themselves benefit from interventions. The aim of this study was to evaluate health-related quality of life in patients with asthma switched from conventional chlorofluorocarbon (CFC) beclomethasone dipropionate (BDP) to hydrofluroalkane-134a (HFA) BDP extrafine aerosol at half the daily dose.Design: Open-label, 12-month, parallel-group, randomized trial. Setting: Fifty-seven centers in four countries (United States, Belgium, the Netherlands, and United Kingdom).Patients: Four hundred seventy-three patients with a greater than or equal to 6-month history of asthma, stable symptoms, and maintained on CFC-BDP, 400 to 1,600 mug/d.Interventions: HFA-BDP, 200 to 800 mug/d (n = 354), or CFC-BDP, 400 to 1,600 mug/d (n = 119).Measurements and results: The Asthma Quality of Life Questionnaire (AQLQ) and pulmonary function tests were completed at months 0, 2, 4, 8, and 12. For 1 month before each visit, patients made daily recordings of symptoms, peak expiratory flow, and beta(2)-agonist use. Two hundred ninety-six patients completed the study (HFA-BDP, 83.6%; CFC-BDP, 83.2%). At month 12, improvements in overall AQLQ scores were greater in the HFA-BDP group than in the CFC-BDP group (p = 0.0024). The number of patients who need to be treated with HFA-BDP for one to have a clinically important improvement in overall asthma-specific quality of life compared with CFC-BDP was 7.3. There was no evidence of differences (p > 0.05) between treatment groups for airway caliber, symptoms, or beta(2)-agonist use.Conclusion: Clinically important improvements in the AQLQ score were observed at month 12 for HFA-BDP vs CFC-BDP, while conventional clinical indexes of pulmonary function and asthma control were similar in the two groups.

AB - Study objective: Clinical trials of asthma treatments usually use measures of asthma control to assess efficacy. However, it is also important to determine whether patients themselves benefit from interventions. The aim of this study was to evaluate health-related quality of life in patients with asthma switched from conventional chlorofluorocarbon (CFC) beclomethasone dipropionate (BDP) to hydrofluroalkane-134a (HFA) BDP extrafine aerosol at half the daily dose.Design: Open-label, 12-month, parallel-group, randomized trial. Setting: Fifty-seven centers in four countries (United States, Belgium, the Netherlands, and United Kingdom).Patients: Four hundred seventy-three patients with a greater than or equal to 6-month history of asthma, stable symptoms, and maintained on CFC-BDP, 400 to 1,600 mug/d.Interventions: HFA-BDP, 200 to 800 mug/d (n = 354), or CFC-BDP, 400 to 1,600 mug/d (n = 119).Measurements and results: The Asthma Quality of Life Questionnaire (AQLQ) and pulmonary function tests were completed at months 0, 2, 4, 8, and 12. For 1 month before each visit, patients made daily recordings of symptoms, peak expiratory flow, and beta(2)-agonist use. Two hundred ninety-six patients completed the study (HFA-BDP, 83.6%; CFC-BDP, 83.2%). At month 12, improvements in overall AQLQ scores were greater in the HFA-BDP group than in the CFC-BDP group (p = 0.0024). The number of patients who need to be treated with HFA-BDP for one to have a clinically important improvement in overall asthma-specific quality of life compared with CFC-BDP was 7.3. There was no evidence of differences (p > 0.05) between treatment groups for airway caliber, symptoms, or beta(2)-agonist use.Conclusion: Clinically important improvements in the AQLQ score were observed at month 12 for HFA-BDP vs CFC-BDP, while conventional clinical indexes of pulmonary function and asthma control were similar in the two groups.

KW - asthma

KW - beclomethasone dipropionate

KW - chlorofluorocarbon

KW - clinical trial

KW - hydrofluoroalkane-134a

KW - inhaled corticosteroids

KW - metered-dose inhaler

KW - quality of life

KW - 400 MU-G

KW - OF-LIFE

KW - MODERATE ASTHMA

KW - TRIALS

KW - QUESTIONNAIRE

KW - EFFICACY

KW - AEROSOL

U2 - 10.1378/chest.121.6.1824

DO - 10.1378/chest.121.6.1824

M3 - Article

VL - 121

SP - 1824

EP - 1832

JO - Chest

JF - Chest

SN - 0012-3692

IS - 6

ER -