Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study
| Autor: | Jack Nyberg, Alberto Papi, Paul Dorinsky, Gary T. Ferguson, Christy Cappelletti, Antonio Anzueto, Edward Kerwin, Elizabeth A. Duncan |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Pulmonary and Respiratory Medicine
Budesonide Male medicine.medical_specialty Internationality Exacerbation Socio-culturale formoterol fumarate dihydrate COPD exacerbations Gastroenterology 03 medical and health sciences Pulmonary Disease Chronic Obstructive 0302 clinical medicine Double-Blind Method Internal medicine Forced Expiratory Volume Formoterol Fumarate Administration Inhalation medicine COPD Humans 030212 general & internal medicine Metered Dose Inhalers Aged integumentary system business.industry Area under the curve Original Articles Middle Aged medicine.disease Metered-dose inhaler Dry-powder inhaler Bronchodilator Agents Treatment Outcome 030228 respiratory system Budesonide/formoterol Drug Therapy Combination Female Formoterol business medicine.drug |
| Zdroj: | The European Respiratory Journal |
| Popis: | TELOS compared budesonide (BD)/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history. In this phase III, double-blind, parallel-group, 24-week study (NCT02766608), patients were randomised to BFF MDI 320/10 µg (n=664), BFF MDI 160/10 µg (n=649), FF MDI 10 µg (n=648), BD MDI 320 µg (n=209) or open-label budesonide/formoterol DPI 400/12 µg (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV1) and FEV1 area under the curve from 0–4 h (AUC0–4). Time to first and rate of moderate/severe exacerbations were assessed. BFF MDI 320/10 µg improved pre-dose trough FEV1 versus FF MDI (least squares mean (LSM) 39 mL; p=0.0018), and BFF MDI 320/10 µg and 160/10 µg improved FEV1 AUC0–4 versus BD MDI (LSM 173 mL and 157 mL, respectively; both p TELOS: co-suspension delivery technology budesonide/formoterol fumarate dihydrate in a metered dose inhaler improved lung function and time to first and rate of exacerbations versus monocomponents in patients with moderate to very severe COPD http://ow.ly/ffWo30lrJL6 |
| Databáze: | OpenAIRE |
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