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 language | English |
|---|---|
| Pages (from-to) | 1824-1832 |
| Number of pages | 8 |
| Journal | Chest |
| Volume | 121 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 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
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. / Juniper, E. F.; Price, David Brendan; Stampone, P. A.; Creemers, J. P. H. M.; Mol, S. J. M.; Fireman, P.
In: Chest, Vol. 121, No. 6, 06.2002, p. 1824-1832.Research output: Contribution to journal › Article
}
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 -