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document
Efficacy of nebulized flunisolide combined with salbutamol and ipratropium bromide in stable patients with moderate-to-severe chronic obstructive pulmonary disease . BACKGROUND The efficacy of nebulized corticosteroids in the prevention of exacerbation of chronic obstructive pulmonary disease ( COPD ) has been poorly studied . OBJECTIVE To evaluate the efficacy and tolerability of nebulized flunisolide ( 1 mg ) + salbutamol/ipratropium bromide ( 1,875/375 microg ) b.i.d . in comparison with placebo + salbutamol/ipratropium bromide . METHODS This was a randomized , parallel-group , double-blind study on 114 patients with COPD of moderate-to-severe degree . The main outcome was the frequency of severe exacerbations over a 6-month period . Before and after treatment , respiratory symptoms , forced expiratory volume in 1 s ( FEV ( 1 ) ) , shuttle walking test distance and St. George 's Respiratory Questionnaire scores were evaluated . RESULTS The total number of exacerbations was slightly lower in the flunisolide group compared to the placebo group ( 19 vs. 34 , p = 0.054 ) ; the number of patients experiencing at least one exacerbation during the study was also decreased ( 16 vs. 26 , p = 0.059 ) . In particular , type 3 Anthonisens 's exacerbations were significantly reduced by flunisolide ( p = 0.044 ) . In the placebo group , scores were higher than in the flunisolide group but nonsignificant for dyspnea , cough , sputum amount and purulence . FEV ( 1 ) was significantly increased compared to baseline in both groups , and the area under the FEV ( 1 ) -time curve during the 6-month period was significantly greater in the flunisolide group ( 5.2 +/- 10.6 vs. 2.1 +/- 5.0 , flunisolide vs. placebo , respectively ; p = 0.047 ) . For shuttle walking test distance and scores of the St. George 's Respiratory Questionnaire , no significant difference between the baseline evaluation and the end of the study was observed in both groups . CONCLUSIONS Nebulized flunisolide is a good alternative to other inhaled corticosteroids when added to nebulized salbutamol/ipratropium bromide in the long-term treatment of moderate-to-severe COPD patients .
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Intervention_Pharmacological
nebulized flunisolide combined with salbutamol and ipratropium bromide
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Intervention_Pharmacological
corticosteroids
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Intervention_Pharmacological
nebulized flunisolide
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Intervention_Pharmacological
+ salbutamol/ipratropium bromide
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Intervention_Control
placebo
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Intervention_Control
salbutamol/ipratropium bromide
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Intervention_Pharmacological
flunisolide
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Intervention_Control
placebo
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Intervention_Pharmacological
flunisolide
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Intervention_Control
placebo
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Intervention_Pharmacological
flunisolide
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Intervention_Pharmacological
flunisolide
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Intervention_Pharmacological
flunisolide
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Intervention_Control
placebo
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Intervention_Pharmacological
Nebulized flunisolide
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Intervention_Pharmacological
nebulized salbutamol/ipratropium bromide
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Outcome_Other
Efficacy
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Outcome_Other
efficacy
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Outcome_Other
efficacy
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Outcome_Other
tolerability
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Outcome_Physical
frequency of severe exacerbations
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Outcome_Physical
respiratory symptoms , forced expiratory volume in 1 s ( FEV ( 1 ) ) , shuttle walking test distance and St. George 's Respiratory Questionnaire scores
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Outcome_Physical
total number of exacerbations
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Outcome_Physical
number of patients experiencing at least one exacerbation during the study
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Outcome_Physical
type 3 Anthonisens 's exacerbations
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Outcome_Adverse-effects
dyspnea , cough , sputum amount and purulence
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Outcome_Physical
FEV ( 1 )
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Outcome_Physical
area under the FEV ( 1 ) -time curve during the 6-month period
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Outcome_Physical
shuttle walking test distance and scores of the St. George 's Respiratory Questionnaire
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Participant_Condition
moderate-to-severe chronic obstructive pulmonary disease
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Participant_Condition
COPD )
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Participant_Sample-size
114
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Participant_Condition
COPD of moderate-to-severe degree
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Participant_Condition
moderate-to-severe COPD