Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma.
RATIONALE: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. OBJECTIVES: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. METHODS: Adults who were symptomatic despite treatme...
| Main Authors: | , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
2007
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| _version_ | 1797058130560942080 |
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| author | Pavord, I Cox, G Thomson, N Rubin, A Corris, P Niven, R Chung, K Laviolette, M |
| author_facet | Pavord, I Cox, G Thomson, N Rubin, A Corris, P Niven, R Chung, K Laviolette, M |
| author_sort | Pavord, I |
| collection | OXFORD |
| description | RATIONALE: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. OBJECTIVES: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. METHODS: Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 mug/day, a long-acting beta(2)-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). MEASUREMENTS AND MAIN RESULTS: BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 +/- 40.1 vs. -1.5 +/- 11.7 puffs/7 d, P < 0.05), prebronchodilator FEV(1)% predicted (14.9 +/- 17.4 vs. -0.94 +/- 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 +/- 1.03 vs. -0.13 +/- 1.00, P = 0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks. CONCLUSIONS: BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539). |
| first_indexed | 2024-03-06T19:46:11Z |
| format | Journal article |
| id | oxford-uuid:2260626b-dafd-4de7-92c3-3d8f61e1504e |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T19:46:11Z |
| publishDate | 2007 |
| record_format | dspace |
| spelling | oxford-uuid:2260626b-dafd-4de7-92c3-3d8f61e1504e2022-03-26T11:38:30ZSafety and efficacy of bronchial thermoplasty in symptomatic, severe asthma.Journal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:2260626b-dafd-4de7-92c3-3d8f61e1504eEnglishSymplectic Elements at Oxford2007Pavord, ICox, GThomson, NRubin, ACorris, PNiven, RChung, KLaviolette, M RATIONALE: Bronchial thermoplasty (BT) is designed to reduce airway smooth muscle and improve asthma control. OBJECTIVES: This study was conducted to determine the safety and efficacy of this procedure in subjects with symptomatic, severe asthma. METHODS: Adults who were symptomatic despite treatment with fluticasone or equivalent at more than 750 mug/day, a long-acting beta(2)-agonist, and other medications, which could include 30 mg or less of oral prednisolone/day, were randomized to BT or to a control group. After treatment, subjects entered a 16-week steroid stable phase (Weeks 6-22), a 14-week steroid wean phase (Weeks 22-36), and a 16-week reduced steroid phase (Weeks 36-52). MEASUREMENTS AND MAIN RESULTS: BT resulted in a transient worsening of asthma symptoms. Seven hospitalizations for respiratory symptoms occurred in 4 of 15 BT subjects during the treatment period. Five hospitalizations were within 3 days of treatment. Two subjects had segmental collapse involving the most recently treated lobe; one required bronchoscopy and aspiration of a mucus plug. There were no hospitalizations during this period in the 17 control subjects. The rate of hospitalizations was similar in both groups in the post-treatment period. At 22 weeks, BT subjects had significant improvements versus control subjects in rescue medication use (-26.6 +/- 40.1 vs. -1.5 +/- 11.7 puffs/7 d, P < 0.05), prebronchodilator FEV(1)% predicted (14.9 +/- 17.4 vs. -0.94 +/- 22.3%, P = 0.04), and Asthma Control Questionnaire scores (-1.04 +/- 1.03 vs. -0.13 +/- 1.00, P = 0.02). Improvements in rescue medication use and Asthma Control Questionnaire scores remained significantly different from those of controls at 52 weeks. CONCLUSIONS: BT is associated with a short-term increase in asthma-related morbidity. However, there is preliminary evidence of long-lasting improvement in asthma control. Clinical trial registered with www.clinicaltrials.gov (NCT 00214539). |
| spellingShingle | Pavord, I Cox, G Thomson, N Rubin, A Corris, P Niven, R Chung, K Laviolette, M Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title | Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title_full | Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title_fullStr | Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title_full_unstemmed | Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title_short | Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. |
| title_sort | safety and efficacy of bronchial thermoplasty in symptomatic severe asthma |
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