A phase IIb, randomised, parallel-group study : the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids
BACKGROUND: Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist.
METHODS: This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) and clinic FEV1 3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV1, evening FEV1, morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study.
RESULTS: The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo. No new safety signals were identified.
CONCLUSIONS: UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg).
TRIAL REGISTRATION: GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2020 |
|---|---|
| Erschienen: |
2020 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:21 |
|---|---|
| Enthalten in: |
Respiratory research - 21(2020), 1 vom: 12. Juni, Seite 148 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Kerwin, Edward [VerfasserIn] |
|---|
| Links: |
|---|
| Anmerkungen: |
Date Completed 06.05.2021 Date Revised 06.05.2021 published: Electronic ClinicalTrials.gov: NCT03012061 Citation Status MEDLINE |
|---|
| doi: |
10.1186/s12931-020-01400-5 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM311114148 |
|---|
| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM311114148 | ||
| 003 | DE-627 | ||
| 005 | 20231225141549.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231225s2020 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1186/s12931-020-01400-5 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1037.xml |
| 035 | |a (DE-627)NLM311114148 | ||
| 035 | |a (NLM)32532275 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Kerwin, Edward |e verfasserin |4 aut | |
| 245 | 1 | 2 | |a A phase IIb, randomised, parallel-group study |b the efficacy, safety and tolerability of once-daily umeclidinium in patients with asthma receiving inhaled corticosteroids |
| 264 | 1 | |c 2020 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 06.05.2021 | ||
| 500 | |a Date Revised 06.05.2021 | ||
| 500 | |a published: Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03012061 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a BACKGROUND: Patients with asthma uncontrolled on inhaled corticosteroids may benefit from umeclidinium (UMEC), a long-acting muscarinic antagonist | ||
| 520 | |a METHODS: This Phase IIb, double-blind study included patients with reversible, uncontrolled/partially-controlled asthma for ≥6 months, receiving ≥100 mcg/day fluticasone propionate (or equivalent) for ≥12 weeks. Following a 2-week run-in on open-label fluticasone furoate (FF) 100 mcg, patients were randomised (1:1:1) to receive UMEC 31.25 mcg, UMEC 62.5 mcg or placebo on top of FF 100 mcg once-daily for 24 weeks. As-needed salbutamol was provided. Primary and secondary endpoints were change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) and clinic FEV1 3 h post-dose, respectively, at Week 24. Other endpoints included change from baseline in home daily spirometry (trough FEV1, evening FEV1, morning [pre-dose] and evening peak expiratory flow) over 24 weeks. Safety was assessed throughout the study | ||
| 520 | |a RESULTS: The intent-to-treat population comprised 421 patients (UMEC 31.25 mcg: n =139, UMEC 62.5 mcg: n =139, placebo: n =143). UMEC 31.25 mcg and 62.5 mcg demonstrated significantly greater improvements from baseline in clinic trough FEV1 at Week 24 (difference [95% CI]: 0.176 L [0.092, 0.260; p<0.001] and 0.184 L [0.101, 0.268; p<0.001], respectively), clinic FEV1 3 h post-dose at Week 24 (0.190 L [0.100, 0.279; p<0.001] and 0.198 L [0.109, 0.287; p<0.001], respectively) and mean change from baseline in daily home spirometry over 24 weeks versus placebo. No new safety signals were identified | ||
| 520 | |a CONCLUSIONS: UMEC is a highly effective bronchodilator that leads to improved lung function when administered as a single bronchodilator on top of FF in subjects with fully reversible, uncontrolled/partially-controlled moderate asthma. These data support a favourable benefit/risk profile for UMEC (31.25 mcg and 62.5 mcg) | ||
| 520 | |a TRIAL REGISTRATION: GSK study ID: 205832; Clinicaltrials.gov ID: NCT03012061 | ||
| 650 | 4 | |a Clinical Trial, Phase II | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Asthma | |
| 650 | 4 | |a Forced expiratory volume in 1 s | |
| 650 | 4 | |a Inhaled corticosteroid | |
| 650 | 4 | |a Long-acting muscarinic antagonist | |
| 650 | 4 | |a Umeclidinium | |
| 650 | 7 | |a Bronchodilator Agents |2 NLM | |
| 650 | 7 | |a GSK573719 |2 NLM | |
| 650 | 7 | |a Glucocorticoids |2 NLM | |
| 650 | 7 | |a Quinuclidines |2 NLM | |
| 650 | 7 | |a Fluticasone |2 NLM | |
| 650 | 7 | |a CUT2W21N7U |2 NLM | |
| 700 | 1 | |a Pascoe, Steven |e verfasserin |4 aut | |
| 700 | 1 | |a Bailes, Zelie |e verfasserin |4 aut | |
| 700 | 1 | |a Nathan, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Bernstein, David |e verfasserin |4 aut | |
| 700 | 1 | |a Dahl, Ronald |e verfasserin |4 aut | |
| 700 | 1 | |a von Maltzahn, Robyn |e verfasserin |4 aut | |
| 700 | 1 | |a Robbins, Kevin |e verfasserin |4 aut | |
| 700 | 1 | |a Fowler, Andrew |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Laurie |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t Respiratory research |d 2000 |g 21(2020), 1 vom: 12. Juni, Seite 148 |w (DE-627)NLM115627553 |x 1465-993X |7 nnns |
| 773 | 1 | 8 | |g volume:21 |g year:2020 |g number:1 |g day:12 |g month:06 |g pages:148 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1186/s12931-020-01400-5 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 21 |j 2020 |e 1 |b 12 |c 06 |h 148 | ||