Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study
Abstract Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma....
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| Format: | Article |
| Language: | English |
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BMC
2020-04-01
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| Series: | Respiratory Research |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12931-020-01349-5 |
| _version_ | 1818202921626501120 |
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| author | Henrik Watz Jens M. Hohlfeld Dave Singh Jutta Beier Zuzana Diamant Jinming Liu Shucheng Hua Khalid Abd-Elaziz Pascale Pinot Ieuan Jones Hanns-Christian Tillmann |
| author_facet | Henrik Watz Jens M. Hohlfeld Dave Singh Jutta Beier Zuzana Diamant Jinming Liu Shucheng Hua Khalid Abd-Elaziz Pascale Pinot Ieuan Jones Hanns-Christian Tillmann |
| author_sort | Henrik Watz |
| collection | DOAJ |
| description | Abstract Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 μg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV1 after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. Trial registration ClinicalTrials.gov, (Identifier: NCT03063086 ), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017. |
| first_indexed | 2024-12-12T03:17:08Z |
| format | Article |
| id | doaj.art-d541d016783b409fa448e2abf8959460 |
| institution | Directory Open Access Journal |
| issn | 1465-993X |
| language | English |
| last_indexed | 2024-12-12T03:17:08Z |
| publishDate | 2020-04-01 |
| publisher | BMC |
| record_format | Article |
| series | Respiratory Research |
| spelling | doaj.art-d541d016783b409fa448e2abf89594602022-12-22T00:40:15ZengBMCRespiratory Research1465-993X2020-04-012111510.1186/s12931-020-01349-5Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over studyHenrik Watz0Jens M. Hohlfeld1Dave Singh2Jutta Beier3Zuzana Diamant4Jinming Liu5Shucheng Hua6Khalid Abd-Elaziz7Pascale Pinot8Ieuan Jones9Hanns-Christian Tillmann10Pulmonary Research Institute at LungenClinic Grosshandorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL)Fraunhofer Institute of Toxicology and Experimental Medicine and Respiratory Medicine of Hannover Medical School, Biomedical Research in End-Stage and Obstructive Lung Disease (BREATH), German Center for Lung Research (DZL)Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation TrustInsaf Respiratory Research InstituteDepartment of Respiratory Medicine & Allergology, Institute for Clinical Science, Skane University Hospital, Lund UniversityShanghai Pulmonary HospitalThe First Hospital of Jilin UniversityQPS-NetherlandsNovartis Institutes for Biomedical ResearchNovartis Pharma AGNovartis Institutes for Biomedical ResearchAbstract Indacaterol (IND; 150 μg), glycopyrronium (GLY; 50 μg) and mometasone furoate (MF; 160 μg [high-dose ICS] and 80 μg [medium-dose ICS]) have been formulated as a once-daily (o.d.) fixed-dose combination treatment delivered via the Breezhaler® device for the treatment of patients with asthma. In this randomized (n = 116), double-blind, double-dummy, active comparator-controlled, three-period cross-over study we evaluated the benefit of o.d. IND/GLY/MF versus twice daily (b.i.d.) salmeterol/fluticasone propionate combination (SFC; 50/500 μg; high-dose ICS) treatment (NCT03063086). Overall, 107 patients completed the study. The study met its primary objective by demonstrating superiority of o.d. IND/GLY/MF at medium and high-dose ICS over b.i.d. SFC (high-dose ICS) in peak FEV1 after 21 days of treatment (+ 172 mL with high-dose and + 159 mL with medium-dose IND/GLY/MF versus SFC, p < 0.0001 for each comparison). We also observed that a higher percentage of patients did not need rescue medicine with IND/GLY/MF (high-dose ICS, 58%; medium-dose ICS, 52%) compared with SFC (45%) during the last week of each treatment period. Study treatments were well-tolerated with no relevant differences in tolerability between both IND/GLY/MF doses and SFC. In conclusion, both doses of IND/GLY/MF provided superior lung function benefits compared with twice-daily, standard-of-care SFC at the highest approved dose. Trial registration ClinicalTrials.gov, (Identifier: NCT03063086 ), EudraCT start date: May 11, 2017; First patient first visit / study initiation date: May 31, 2017.http://link.springer.com/article/10.1186/s12931-020-01349-5IndacaterolGlycopyrroniumMometasone FuroateAsthma |
| spellingShingle | Henrik Watz Jens M. Hohlfeld Dave Singh Jutta Beier Zuzana Diamant Jinming Liu Shucheng Hua Khalid Abd-Elaziz Pascale Pinot Ieuan Jones Hanns-Christian Tillmann Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study Respiratory Research Indacaterol Glycopyrronium Mometasone Furoate Asthma |
| title | Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study |
| title_full | Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study |
| title_fullStr | Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study |
| title_full_unstemmed | Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study |
| title_short | Letter to the editor: indacaterol/glycopyrronium/mometasone furoate compared with salmeterol/fluticasone propionate in patients with asthma: a randomized controlled cross-over study |
| title_sort | letter to the editor indacaterol glycopyrronium mometasone furoate compared with salmeterol fluticasone propionate in patients with asthma a randomized controlled cross over study |
| topic | Indacaterol Glycopyrronium Mometasone Furoate Asthma |
| url | http://link.springer.com/article/10.1186/s12931-020-01349-5 |
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