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- | glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Anoro Ellipta (umeclidinium + vilanterol) / Innoviva, GSK
Journal: Inhaled Triple Therapy in Severe Chronic Obstructive Pulmonary Disease (COPD) (Pubmed Central) - Aug 3, 2019
Beclometasone/formoterol/glycolpyrronium and fluticasonfuroate/umeclidinium/vilanterol are the first triple combination therapies approved in a fixed-dose inhaler for COPD patients. The domains of triple fixed-dose formulations are COPD patients in groups C and D.
- | glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
Clinical, Journal: Medication adherence and persistence in chronic obstructive pulmonary disease patients receiving triple therapy in a USA commercially insured population. (Pubmed Central) - Aug 1, 2019
Mean PDC for each single inhaler component was higher than the mean PDC observed with MITT. Reducing the number of inhalers may improve overall adherence to intended triple therapy.
- | glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis
Clinical, Journal: Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. (Pubmed Central) - Aug 1, 2019
P3
In patients with symptomatic COPD, FEV <50%, and an exacerbation history, extrafine BDP/FF/G delayed disease deterioration compared with BDP/FF, tiotropium, and IND/GLY. The studies are registered in ClinicalTrials.gov: TRILOGY, NCT01917331; TRINITY, NCT01911364; TRIBUTE, NCT02579850.
- | glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis, Trelegy Ellipta (fluticasone furoate/umeclidinium bromide/vilanterol) / GSK, Innoviva
Review, Journal: Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. (Pubmed Central) - Jul 4, 2019
...Of the five main fixed triple studies completed so far, three evaluated the efficacy and safety of an extrafine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium; the other two studies evaluated fluticasone furoate, vilanterol, and umeclidinium...The evidence suggests that triple therapy is the most effective treatment in moderate/severe symptomatic patients with COPD at risk of exacerbations, with marginal if any risk of side effects including pneumonia. Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD and asthma-COPD overlap.
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment closed, Head-to-Head: ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) - Jun 13, 2019
P3, N=1432, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD and asthma-COPD overlap. Recruiting --> Active, not recruiting
- ||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion, Trial initiation date: Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. (clinicaltrials.gov) - Mar 28, 2019
P2, N=116, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting Recruiting --> Completed | Initiation date: May 2017 --> Jan 2017
- ||| glycopyrrolate/indacaterol/mometasone (QVM149) / Novartis
P3 data: Vectura FY revenues +8.4%; Adjusted EBITDA +51.2%, operating loss +9.6%, operating cash +30%; expects 2019 updates on VR315 resubmission with Hikma, partnering of VR647, further progress on our new nebulised assets and Phase III study completion for QVM149 (Twitter) - Mar 26, 2019
- || Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial completion: Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (clinicaltrials.gov) - Jun 8, 2018
P2, N=38, Completed, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed | Initiation date: May 2017 --> Jan 2017 Recruiting --> Completed
- |||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment open, Head-to-Head: ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) - Mar 12, 2018
P3, N=1500, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Completed Not yet recruiting --> Recruiting
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment closed, Trial initiation date: A Long-term Safety Study of QVM149 in Japanese Patients With Asthma (clinicaltrials.gov) - Mar 9, 2018
P3, N=93, Active, not recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Initiation date: Apr 2017 --> Oct 2016
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial completion date, Trial initiation date, Trial primary completion date: IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) - Mar 7, 2018
P3, N=2980, Recruiting, Sponsor: Novartis Pharmaceuticals
Recruiting --> Active, not recruiting | Initiation date: Apr 2017 --> Oct 2016 Trial completion date: Apr 2019 --> Jun 2019 | Initiation date: Dec 2015 --> Feb 2015 | Trial primary completion date: Apr 2019 --> Jun 2019
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial initiation date, Trial primary completion date, Head-to-Head: ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) - Mar 3, 2018
P3, N=1500, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
Trial completion date: Apr 2019 --> Jun 2019 | Initiation date: Dec 2015 --> Feb 2015 | Trial primary completion date: Apr 2019 --> Jun 2019 Initiation date: Jan 2018 --> Feb 2018 | Trial primary completion date: Mar 2019 --> Jun 2019
- |||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. (clinicaltrials.gov) - Mar 2, 2018
P2, N=114, Recruiting, Sponsor: Novartis Pharmaceuticals
Initiation date: Jan 2018 --> Feb 2018 | Trial primary completion date: Mar 2019 --> Jun 2019 Not yet recruiting --> Recruiting | Trial completion date: Jul 2018 --> Aug 2018 | Initiation date: May 2017 --> May 2017 | Trial primary completion date: Jul 2018 --> Aug 2018
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial initiation date: Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (clinicaltrials.gov) - Jan 16, 2018
P2, N=36, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial completion date: Jul 2018 --> Aug 2018 | Initiation date: May 2017 --> May 2017 | Trial primary completion date: Jul 2018 --> Aug 2018 Initiation date: Jun 2017 --> Jan 2017
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Trial initiation date, Head-to-Head: ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) - Nov 22, 2017
P3, N=1251, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
Initiation date: Jun 2017 --> Jan 2017 Initiation date: Oct 2017 --> Jan 2018
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment open: Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (clinicaltrials.gov) - Jul 14, 2017
P2, N=36, Recruiting, Sponsor: Novartis Pharmaceuticals
Initiation date: Oct 2017 --> Jan 2018 Not yet recruiting --> Recruiting
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New P3 trial, Head-to-Head: ARGON: Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + Tiotropium (clinicaltrials.gov) - May 18, 2017
P3, N=1500, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- |||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
Enrollment open, Trial primary completion date: A Long-term Safety Study of QVM149 in Japanese Patients With Asthma (clinicaltrials.gov) - May 18, 2017
P3, N=100, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting | Trial primary completion date: May 2019 --> Nov 2018
- |||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Trial primary completion date: IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) - May 3, 2017
P3, N=2980, Recruiting, Sponsor: Novartis Pharmaceuticals
Not yet recruiting --> Recruiting | Trial primary completion date: May 2019 --> Nov 2018 Trial primary completion date: Oct 2018 --> Apr 2019
- | Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New P2 trial: Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (clinicaltrials.gov) - Apr 10, 2017
P2, N=36, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New P3 trial: A Long-term Safety Study of QVM149 in Japanese Patients With Asthma (clinicaltrials.gov) - Apr 4, 2017
P3, N=100, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- ||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis
New P2 trial: Assess Bronchodilator Effect and Safety of Two Doses of QVM149 Compared to a Fixed Dose Combination of Salmeterol/Fluticasone in Patients With Asthma. (clinicaltrials.gov) - Feb 24, 2017
P2, N=114, Not yet recruiting, Sponsor: Novartis Pharmaceuticals
- |||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
Enrollment open, Trial primary completion date: IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) - Jul 11, 2016
P3, N=3155, Recruiting, Sponsor: Novartis Pharmaceuticals
Trial primary completion date: Oct 2018 --> Apr 2019 Not yet recruiting --> Recruiting | Trial primary completion date: Apr 2018 --> Oct 2018
- |||||||||| Enerzair Breezhaler (glycopyrrolate/indacaterol/mometasone) / Novartis, Atectura Breezhaler (indacaterol/mometasone furoate) / Novartis, Merck (MSD)
New P3 trial: IRIDIUM: Study to Compare the Efficacy and Safety of QVM149 With QMF149 in Patients With Asthma (clinicaltrials.gov) - Oct 22, 2015
P3, N=3155, Not yet recruiting, Sponsor: Novartis Pharmaceuticals