[Translation] A randomized, open-label, two-dose, single-dose bioequivalence study of indacaterol mometasone inhalation powder (III) in Chinese healthy subjects under fasting conditions

主要目的：以北京抗创联生物制药技术研究有限公司研发的茚达特罗莫米松吸入粉雾剂（Ⅲ）（规格：150 μg /320 μg）为受试制剂，按生物等效性试验的有关规定，以Novartis Pharma AG 持证的茚达特罗莫米松吸入粉雾剂（Ⅲ）（规格：150 μg /320 μg；商品名：Atectura® Breezhaler®）为参比制剂，对比在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察受试制剂茚达特罗莫米松吸入粉雾剂（Ⅲ）和参比制剂茚达特罗莫米松吸入粉雾剂（Ⅲ）（Atectura® Breezhaler®）在健康受试者中的安全性。

[Translation]

Main purpose: Indacaterol mometasone inhalation powder (III) (specification: 150 μg / 320 μg) developed by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd. was used as the test preparation. According to the relevant provisions of the bioequivalence test, indacaterol mometasone inhalation powder (III) (specification: 150 μg / 320 μg; trade name: Atectura® Breezhaler®) certified by Novartis Pharma AG was used as the reference preparation. The absorption rate and degree of absorption in healthy humans were compared to investigate the bioequivalence of the two preparations in humans. Secondary purpose: To observe the safety of the test preparation indacaterol mometasone inhalation powder (III) and the reference preparation indacaterol mometasone inhalation powder (III) (Atectura® Breezhaler®) in healthy subjects.

Start Date30 May 2024

Sponsor / Collaborator

Beijing Kangchuanglian Biopharmaceutical Technology Research

NCT05562466 / RecruitingPhase 3

Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma

The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.
* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.
* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.

Start Date11 May 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT04589663 / CompletedPhase 2

An Open-label, Two-period, Single-sequence, Crossover Study to Compare the Systemic Exposure of a Single Inhaled Dose of Mometasone Furoate (MF) When Administered Alone Via the MF Twisthaler® (TH) to a Single Inhaled Dose of QMF149 Indacaterol Acetate/MF Fixed Dose Combination When Administered Via the Concept 1 (C1) Breezhaler® Device in ≥ 6 to < 12 Year Old Asthma Patients

This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed dose combination (QMF149) via the Concept 1 (C1) device in pediatric asthma patients.

Start Date07 Jun 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with Indacaterol Acetate/Mometasone Furoate

100 Translational Medicine associated with Indacaterol Acetate/Mometasone Furoate

100 Patents (Medical) associated with Indacaterol Acetate/Mometasone Furoate

Literatures (Medical) associated with Indacaterol Acetate/Mometasone Furoate

01 Oct 2023·Respiratory medicine

Efficacy of mometasone/indacaterol/glycopyrronium in patients with inadequately controlled asthma with respect to baseline eosinophil count: Post hoc analysis of IRIDIUM study.

Article

Author: Maspero, Jorge F ; Mezzi, Karen ; Chapman, Kenneth R ; Lawrence, David ; Kostikas, Konstantinos ; van Zyl-Smit, Richard ; Jaumont, Xavier

BACKGROUND:

Baseline characteristics could potentially guide asthma treatments. We evaluated whether baseline eosinophil levels affect the efficacy of mometasone/indacaterol/glycopyrronium (MF/IND/GLY) in patients with inadequately controlled asthma.

METHOD:

In this post hoc analysis of IRIDIUM study, efficacy of high-dose MF/IND/GLY (160/150/50 μg, once-daily [o.d.]) versus high-dose MF/IND (320/150 μg o.d.) and high-dose fluticasone/salmeterol (FLU/SAL [500/50 μg, twice-daily [b.i.d.]); and efficacy of pooled MF/IND/GLY (160/150/50 μg and 80/150/50 μg) versus pooled MF/IND (320/150 μg and 160/150 μg) was evaluated in patient subgroups with baseline blood eosinophil count of <300 cells/μL or ≥300 cells/μL.

RESULTS:

Overall, 3065 patients were included. At Week 26, high-dose MF/IND/GLY showed improved trough FEV₁ versus high-dose MF/IND (Δ78mL [<300 cells/μL]; Δ54mL [≥300 cells/μL]) and FLU/SAL (Δ112mL [<300 cells/μL]; Δ98mL [≥300 cells/μL]). Similarly, pooled MF/IND/GLY also showed improved trough FEV₁ versus pooled MF/IND (Δ75mL [<300 cells/μL]; Δ68mL [≥300 cells/μL]). Over 52 weeks, high-dose MF/IND/GLY reduced the annualized rate of moderate or severe asthma exacerbations by 23% and 10%, severe exacerbations by 31% and 15%, and all exacerbation by 33% and 10% versus high-dose MF/IND for subgroups with <300 cells/μL and ≥300 cells/μL, respectively; and by 33% and 41%, 45% and 42%, 42% and 39% versus FLU/SAL, respectively. Similarly, pooled MF/IND/GLY reduced exacerbations by 22% and 8%, 21% and 7%, 27% and 8%, versus pooled MF/IND, for the respective subgroups.

CONCLUSION:

MF/IND/GLY showed improvement in lung function and reduction in asthma exacerbations over MF/IND and FLU/SAL independent of baseline eosinophil levels, indicating that eosinophil levels did not affect the efficacy of MF/IND/GLY in patients with inadequately controlled asthma.

TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02571777 (IRIDIUM).

01 Apr 2023·Chest

Comparison of Clinical Outcomes Among Different Fixed-Dose Combinations of Long-Acting Muscarinic Antagonists and Long-Acting β2-Agonists in Patients With COPD

Article

Author: Wu, Chien-Chih ; Wu, Mei-Hsuan ; Weng, Ching-Fu ; Lin, Fang-Ju

BACKGROUND:

Researchers have yet to obtain conclusive evidence differentiating among fixed-dose combinations (FDCs) of long-acting muscarinic antagonists (LAMAs) and long-acting β₂-agonists (LABAs) for COPD in terms of real-world clinical outcomes.

RESEARCH QUESTION:

What are the differences between available LAMA/LABA FDCs in the risk of acute exacerbation (AE) and cardiovascular events?

STUDY DESIGN AND METHODS:

This retrospective cohort study based on a national insurance claims database included patients with COPD ≥ 40 years of age who were newly prescribed glycopyrronium (GLY)/indacaterol (IND), umeclidinium (UMEC)/vilanterol (VI), or tiotropium (TIO)/olodaterol (OLO) FDC between January 1, 2015, and June 30, 2019. Propensity score matching and Cox regression models were used to compare outcomes of AE and cardiovascular events associated with LAMA/LABA FDC treatment.

RESULTS:

Among the 44,498 patients identified and included, 15,586 received GLY/IND, 20,460 received UMEC/VI, and 8,452 received TIO/OLO. Baseline characteristics were well balanced after 1:1 matching of UMEC/VI and GLY/IND, 2:1 matching of UMEC/VI and TIO/OLO, and 2:1 matching of GLY/IND and TIO/OLO. Risk of severe AE was lower among patients treated with UMEC/VI or GLY/IND than among those who received TIO/OLO (UMEC/VI vs TIO/OLO: 17.85 vs 29.32 per 100 person-years; hazard ratio, 0.76; 95% CI, 0.68-0.84; GLY/IND vs TIO/OLO: 15.54 vs 25.53 per 100 person-years; hazard ratio, 0.77; 95% CI, 0.67-0.88). In addition, GLY/IND users tended to have a lower risk of cardiovascular events than TIO/OLO users, but the difference dissipated when restricting follow up to a shorter duration.

INTERPRETATION:

Our results revealed that the risk of severe AE was lower among patients with COPD receiving UMEC/VI or GLY/IND than among those receiving TIO/OLO, whereas the incidence of cardiovascular events was similar across groups but was slightly lower in GLY/IND users when compared with TIO/OLO users. Further research will be required to confirm these findings.

01 Jun 2022·Advances in therapyQ3 · MEDICINE

A Review of the Unique Drug Development Strategy of Indacaterol Acetate/Glycopyrronium Bromide/Mometasone Furoate: A First-in-Class, Once-Daily, Single-Inhaler, Fixed-Dose Combination Treatment for Asthma

Q3 · MEDICINE

Review

Author: Pethe, Abhijit ; Jauernig, Juergen ; Scosyrev, Emil ; Gruen, Emilie ; Brittain, Dominic ; Tanase, Ana-Maria ; D'Andrea, Peter ; Hosoe, Motoi ; Jain, Devendra ; Tillmann, Hanns-Christian

A novel, once-daily (o.d.), fixed-dose combination (FDC) of indacaterol acetate (IND), glycopyrronium bromide (GLY), and mometasone furoate (MF), delivered by the inhaler Breezhaler^® device, is the first long-acting beta2-adrenergic agonist/long-acting muscarinic antagonist/inhaled corticosteroid (LABA/LAMA/ICS) therapy to be approved for maintenance treatment of asthma in adults inadequately controlled on LABA/ICS. The approval of IND/GLY/MF in the European Union (EU) also included an optional electronic sensor and smartphone (or other suitable device) application, making it the first "digital companion" that can be prescribed with an asthma medication. As a result, the European Medicines Agency included this approval as one of the "outstanding contributions to public health" (for Pneumology/Allergology) in their 2020 highlights report. Alongside IND/GLY/MF, an o.d. LABA/ICS FDC, IND/MF, was also developed and approved. This review outlines the unique strategy used in the accelerated development of IND/GLY/MF that combined various approaches: (1) selecting individual components with established efficacy/safety, (2) bridging doses to optimize efficacy/safety of IND/GLY/MF and IND/MF delivered via the Breezhaler^® device, (3) developing IND/GLY/MF and IND/MF in parallel, and (4) submission for regulatory approval before formal completion of the pivotal phase III studies. IND/GLY/MF and IND/MF were combined in a single-development plan (PLATINUM program), which comprised four phase III studies: QUARTZ and PALLADIUM evaluated IND/MF while IRIDIUM and ARGON evaluated IND/GLY/MF. A unique feature was the inclusion of two LABA/ICS comparators in the pivotal IRIDIUM study-IND/MF as an internal comparator, and high-dose salmeterol xinafoate/fluticasone propionate (SAL/FLU) as a marketed comparator. In the ARGON study, IND/GLY/MF was compared against o.d. tiotropium (via Respimat^®) plus twice-daily (b.i.d.) high-dose SAL/FLU (via Diskus^®). As a result of this development strategy, the development and approval of IND/GLY/MF was accelerated by ca. 4 years as against what would be expected from a traditional approach, novel data were generated, and a unique optional digital companion was approved in the EU. A Video Abstract by Dr Dominic Brittain, Global Drug Development, Novartis. (MP4 228293 kb).

News (Medical) associated with Indacaterol Acetate/Mometasone Furoate

27 Apr 2021

·www.biospace.com

Valeo Pharma Upsizes And Closes $6.6 Million Non-Brokered Private Placement

Valeo insiders participation of $2.6 million MONTRÉAL, April 27, 2021 /PRNewswire/ - Valeo Pharma Inc. (CSE: VPH) (OTCQB: VPHIF) (FSE: VP2) ("Valeo" or the "Company"), a Canadian pharmaceutical company, announced today that it has upsized and closed a $6.645 million non-brokered private placement of unsecured non-convertible debenture units (the "Private Placement"). The Company issued 6,645 unsecured non-convertible debentures units (the "Debenture Units") at a purchase price of $1,000 per Debenture Unit for gross proceeds of $6,645,000. Each Debenture Unit consist of one (1) unsecured non-convertible debenture of the Company in the principal amount of $1,000 (each, a "Debenture") and 200 Class "A" share purchase warrants (each, a "Warrant"). Each Warrant entitles the holder thereof to purchase one Class "A" Share of the Company (each, a "Share") at an exercise price of $1.60 at any time up to 24 months following the closing date of the Offering (the "Closing Date"). The Debentures will mature at the latest 9 months after the closing and bear interest at a rate of 8% per annum from the date of issue, payable in cash, semi-annually in arrears. "The closing of this upsized placement is testament to the confidence and support our insiders and those close to the Company have in management and Valeo's business model", said Steve Saviuk, CEO. "I cannot over emphasize what a pivotal year 2021 is becoming with the recent launch of Redesca® and the imminent launches of Enerzair® Breezhaler® and Atectura® Breezhaler®". The securities issued under the Private Placement are subject to a four-month hold period in accordance with applicable securities legislation. The Company has paid $38,500 as finder's fees to arm's-length parties in connection with the Private Placement and issued a total of 7,700 broker warrants in compliance with applicable securities laws. Insiders, Senior Executives, staff members and 3 Directors of the Company all participated in the Private Placement for an aggregate amount of $2.6 million. The net proceeds of the Offering will be used for working capital and general corporate purposes. Participation of insiders of the Company in the Private Placement constitutes a "related party transaction" as defined under Regulation 61-101 respecting Protection of Minority Security Holders in Special Transactions ("Regulation 61-101"). The Company intends to rely on exemptions from the formal valuation and minority shareholder approval requirements provided under sections 5.5(a) and 5.7(a) of Regulation 61-101 on the basis that participation in the Private Placement by insiders will not exceed 25% of the fair market value of the Company's market capitalization and also because the Company's Common Shares trade only on the Canadian Securities Exchange (CSE). A material change report was not filed in connection with the participation of the insiders in at least 21 days in advance of the closing of the Private Placement, which the Company deemed reasonable in the circumstances, in order to close the transaction as soon as practicable to enable it to use the funds. About Valeo Pharma Valeo Pharma is a Canadian pharmaceutical company dedicated to the commercialization of innovative prescription products in Canada with a focus on Respiratory Diseases, Neurology, Oncology and Hospital Specialty Products. Headquartered in Kirkland, Quebec Valeo Pharma has all the required capabilities and the full infrastructure to register and properly manage its growing product portfolio through all stages of commercialization. For more information, please visit and follow us on LinkedIn and Twitter. Forward Looking Statements This press release contains forward-looking statements about Valeo's objectives, strategies and businesses that involve risks and uncertainties. These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATIONS SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE. Company Codes: OTC-QB:VPHIF, CNSX:VPH, Frankfurt:VP2, OTC-PINK:VPHIF

09 Mar 2011

·www.pharmatimes.com

Novartis COPD drug indacaterol closer to US green light

Advisors to the US regulator have voted to recommend approval of Novartis' chronic obstructive pulmonary disease drug indacaterol but only at the lower of the two doses proposed by the Swiss drugmaker. The Pulmonary-Allergy Drug Advisory Committee of the US Food and Drug Administration has backed QAB149 (indacaterol) 75 mcg as a once-daily long-term maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema. The panel voted 13 to four in favour of that dose, but 12 to five against recommending approval of 150 mcg of indacaterol, a long-acting beta2-agonist (LABA). The PADAC noted that 75 mcg was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses. In October 2009, the FDA issued Novartis with a complete response letter for indacaterol and specifically requested additional information on the dosing. The treatment is already approved in Europe under the tradename Onbrez Breezhaler at 150 and 300 mcg once-daily doses and brought in revenues of $33 million in 2010. If approved in the USA, it will be sold as Arcapta Neohaler. Analysts believe that indacaterol as a monotherapy will only have modest sales but will be lucrative as part of a combo. Jacoba van der Gaag at Datamonitor says that an approval would pave the way for Novartis’ new respiratory franchise, which includes two once-daily combinations using indacaterol; QMF149 with the inhaled corticosteroid mometasone and QVA149 with the long-acting muscarinic antagonist glycopyrrolate. She expects QVA149 to launch in 2013, followed by QMF149 two years later, and Novartis’ indacaterol-containing products to reach $2.4 billion in the seven major markets by 2019, with the majority of sales coming from combos. GlaxoSmithKline’s rival once-daily LABA, GSK642444, is currently in Phase III and a filing is expected later this year but Ms van der Gaag lnotes that COPD patients "have high brand loyalty stemming from hesitation to switch between devices [and] this positive vote for Novartis increases the company’s chances of establishing its brands early, and benefiting from a first mover advantage".

100 Deals associated with Indacaterol Acetate/Mometasone Furoate

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Asthma	CA	Novartis Pharmaceuticals Canada, Inc.	06 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Mild asthma	Phase 3	JP	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	BG	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	CL	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	CO	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	EE	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	DE	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	HU	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	IN	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	IT	Novartis Pharmaceuticals Corp.	16 Jan 2017
Mild asthma	Phase 3	LV	Novartis Pharmaceuticals Corp.	16 Jan 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04589663 (CTgov)	Phase 2	Asthma	24	Standard of Care (Soc)+QMF149+Mometasone furoate	cgujfbbiui(trybivaoch) = jplnezjhrn xvkhbqqbar (blvubgfzat, xoppzkdrcp - dhgkrgfzcl) View more	-	27 Jul 2023
NCT02571777 (IRIDIUM, CTgov)	Phase 3	Asthma	3,092	QVM149 150/50/160 (QVM149 150/50/160 µg o.d.)	ndirfyinnh(dkohsfivgw) = mtihefriou nrxuwmjhgy (bbfhgejgar, tirtjrakmm - plguyhzlvg) View more	-	22 Jul 2020
				QVM149 150/50/80 (QVM149 150/50/80 µg o.d.)	ndirfyinnh(dkohsfivgw) = bslxbmtzem nrxuwmjhgy (bbfhgejgar, lngpmvtssk - xkdppywniu) View more
NCT02554786 (CTgov)	Phase 3	Asthma	2,216	Mometasone furoate	iojzlflnbd(efspqelbbp) = qkrkolmatc wwpfqzouvv (fkjvwtujob, azhvvenjsp - cxqlhzglvx) View more	-	05 Mar 2020
NCT03100500 (CTgov)	Phase 3	Asthma	51	QMF-149 (QMF-149 150/320 μg)	nxuwqyzgxt(twdvkcqtsg) = titgnpkuih yhofgdeulk (zipxmnwceb, jnjaehslxb - nwxofwucad) View more	-	07 Feb 2020
				QMF149 (QMF149 150/320 µg)	ybhxxjlxgo(grwmvuhhzq) = xzemwgtjsb rueajlvsrf (uatzhagijx, fipizbhlgi - qoylzuqtpq) View more
QUARTZ (ERS2019)	Phase 3	Asthma	802	Indacaterol acetate/mometasone furoate 150/80 µg	glrkfmwizl(yimrxgjdnf) = vrkcoleodg jgxvdzbhjf (aipijxffrw, 0.182)	Positive	28 Sep 2019
NCT02892344 (QUARTZ, CTgov)	Phase 3	Mild asthma	802	QMF149 150/80 μg (QMF149 150/80 μg)	kuapvwhgrz(aufcqfivso) = grwtghgdbo bsyhafbmke (wkucbawnoe, vurmnftzgd - ogwmcizkzc) View more	-	12 Sep 2019
				MF 200 μg (MF 200 µg)	kuapvwhgrz(aufcqfivso) = fuwdjjvwqk bsyhafbmke (wkucbawnoe, qtfobjvuzx - fwnegjsenb) View more
NCT01636076 (Pubmed \| Int J Chron Obstruct Pulmon Dis) Manual	Phase 2	Pulmonary Disease, Chronic Obstructive	629	Indacaterol acetate/mometasone furoate	agxybjcoxl(oitbgzcgfr): difference = 56, P-Value = <0.001	Superior	06 Dec 2018
				salmeterol xinafoate/fluticasone propionate
NCT00941798 (Pubmed \| BMJ Open) Manual	Phase 2	Asthma	1,519	QMF149	qdrzonnayv(jpwkmmsegw) = lauutvdrny ttujtnsgqz (hygiipqchz ) View more	Positive	03 Feb 2015
				mometasone furoate	qdrzonnayv(jpwkmmsegw) = gjpknizbsq ttujtnsgqz (hygiipqchz ) View more
NCT01636076 (CTgov)	Phase 2	Pulmonary Disease, Chronic Obstructive	629	QMF149 (QMF149)	hmoooqxzjn(qnasawclqg) = iktubbjuwo udejvdkasi (okqueydurc, eyxmnmwqrl - japrmeaxod) View more	-	17 Nov 2014
				Salmeterol (Salmeterol Xinafoate/Fluticasone Propionate)	hmoooqxzjn(qnasawclqg) = gehfmmfvew udejvdkasi (okqueydurc, onkeqvhuus - ryqrbxvuhg) View more
ERS2014	Not Applicable	Asthma	335	Indacaterol acetate 150 µg	gllujzihey(swgbrvhtqm) = znrswyzzkm posluzzjsd (rqefakiljq )	Positive	01 Sep 2014
				Indacaterol acetate 75 µg	gllujzihey(swgbrvhtqm) = gkitnhredg posluzzjsd (rqefakiljq )

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