Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD

Autor: Władysław Pierzchała, Gabriele Nicolini, Jorg Kampschulte, Mária Szilasi, Jørgen Vestbo, Daniele Guastalla, Claudio Terzano, Dave Singh, Abdullah Sayiner, Massimo Corradi, Eddi Bindi
Přispěvatelé: Ege Üniversitesi
Jazyk: angličtina
Předmět:
Male
Pulmonary and Respiratory Medicine
medicine.medical_specialty
Androstadienes/therapeutic use
Klinikai orvostudományok
Fluticasone propionate
Beclomethasone/administration & dosage
law.invention
Fluticasone-Salmeterol Combination
Pulmonary Disease
Chronic Obstructive

Randomized controlled trial
Double-Blind Method
law
Bronchodilator Agents/administration & dosage
Internal medicine
Ethanolamines/administration & dosage
Formoterol Fumarate
Medicine
Humans
Albuterol
Glucocorticoids
Fluticasone-Salmeterol Drug Combination
COPD
business.industry
Beclomethasone
Glucocorticoids/administration & dosage
Orvostudományok
Middle Aged
respiratory system
medicine.disease
Pulmonary Disease
Chronic Obstructive/drug therapy

Bronchodilator Agents
respiratory tract diseases
Androstadienes
Drug Combinations
Ethanolamines
Albuterol/analogs & derivatives
Female
Formoterol
Salmeterol
business
medicine.drug
Research Article
Zdroj: BMC Pulmonary Medicine
Singh, D, Nicolini, G, Bindi, E, Corradi, M, Guastalla, D, Kampschulte, J, Pierzchala, W, Sayiner, A, Szilasi, M, Terzano, C, Vestbo, J & TherapeUtic, F F U 2014, ' Extrafine Beclomethasone/formoterol compared to Fluticasone/salmeterol Combination Therapy in COPD ', B M C Pulmonary Medicine, vol. 14, 43 . https://doi.org/10.1186/1471-2466-14-43
ISSN: 1471-2466
DOI: 10.1186/1471-2466-14-43
Popis: WOS: 000335358300001
PubMed ID: 24621109
Background: The study evaluated the efficacy of beclomethasone dipropionate/formoterol fumarate (BDP/FF) extrafine combination versus fluticasone propionate/salmeterol (FP/S) combination in COPD patients. Methods: The trial was a 12-week multicentre, randomised, double-blind, double dummy study; 419 patients with moderate/severe COPD were randomised to BDP/FF 200/12 mu g or FP/S 500/50 mu g twice daily. The primary objective was to demonstrate the equivalence between treatments in terms of Transition Dyspnoea Index (TDI) score and the superiority of BDP/FF in terms of change from pre- dose in the first 30 minutes in forced expiratory volume in the first second (FEV1). Secondary endpoints included lung function, symptom scores, symptom-free days and use of rescue medication, St. George's Respiratory Questionnaire, six minute walking test and COPD exacerbations. Results: BDP/FF was equivalent to FP/S in terms of TDI score and superior in terms of FEV1 change from pre- dose (p < 0.001). There were no significant differences between treatments in secondary outcome measures, confirming overall comparability in terms of efficacy and tolerability. Moreover, a clinically relevant improvement (> 4 units) in SGRQ was detected in the BDP/FF group only. Conclusion: BDP/FF extrafine combination provides COPD patients with an equivalent improvement of dyspnoea and a faster bronchodilation in comparison to FP/S.
Chiesi Farmaceutici S.p.A., Parma, Italy
This study was funded by Chiesi Farmaceutici S.p.A., Parma, Italy.
Databáze: OpenAIRE