[Translation] A single-dose, fasting, single-center, randomized, open-label, two-formulation, two-sequence, two-period, two-crossover, pharmacokinetic bioequivalence study of indacatetrosorbone bromide inhalation powder in healthy subjects.

主要目的：以广州呼吸药物工程技术有限公司的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以诺华公司的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，评价受试制剂较参比制剂在空腹条件下单次给药的药代动力学生物等效性。次要目的：评价茚达特罗格隆溴铵吸入粉雾剂在健康受试者单次给药的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic bioequivalence of indacaterol glycopyrronium bromide inhalation powder from Guangzhou Respiratory Pharmaceutical Engineering Technology Co., Ltd. (test formulation) and Novartis' indacaterol glycopyrronium bromide inhalation powder (trade name: JERUN®) under fasting conditions after a single dose. Secondary objective: To evaluate the safety of indacaterol glycopyrronium bromide inhalation powder after a single dose in healthy subjects.

Start Date21 Nov 2025

Sponsor / Collaborator

Guangzhou Jiankangyuan Respiratory Medicine Engineering

CTR20254546

/ RecruitingNot Applicable

茚达特罗格隆溴铵吸入粉雾剂在COPD受试者中的药效动力学研究

[Translation] Pharmacokinetic study of indidatarbutin glycopyrronium bromide inhalation powder in COPD subjects

主要目的以山东京卫制药有限公司生产的茚达特罗格隆溴铵吸入粉雾剂为受试制剂，以Siegfried Barbera, S.L.生产的茚达特罗格隆溴铵吸入粉雾剂（商品名：杰润®）为参比制剂，比较受试制剂（T）和参比制剂（R）在慢性阻塞性肺疾病（COPD）受试者体内的药效动力学特征，评价两制剂在COPD受试者中的PD-BE等效性，为受试制剂的生产注册申请提供支持。次要目的观察受试制剂和参比制剂在COPD受试者中的安全性。

[Translation]

Primary Objective: To compare the pharmacokinetic characteristics of indacatetroglycopyrronium bromide inhalation powder (T) manufactured by Shandong Jingwei Pharmaceutical Co., Ltd., and indacatetroglycopyrronium bromide inhalation powder (trade name: JERUN®) manufactured by Siegfried Barbera, S.L., in subjects with chronic obstructive pulmonary disease (COPD), evaluate the PD-BE equivalence of the two formulations in COPD subjects, and provide support for the production registration application of the investigational formulation. Secondary Objective: To observe the safety of the investigational and reference formulations in COPD subjects.

Start Date18 Nov 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

CTR20253139

/ CompletedNot Applicable

预评估受试制剂茚达特罗格隆溴铵吸入粉雾剂（规格：110 μg/50 μg）与参比制剂（杰润®）（规格：110 μg/50 μg）在健康成年参与者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to preliminarily evaluate the bioequivalence of the test product, indacaterol bromide inhalation powder (110 μg/50 μg), and the reference product (Jierun®) (110 μg/50 μg) in healthy adult participants under fasting conditions.

研究空腹状态下单次经口吸入受试制剂茚达特罗格隆溴铵吸入粉雾剂（规格：110 μg/50 μg，江西艾施特制药有限公司生产）与参比制剂茚达特罗格隆溴铵吸入粉雾剂（杰润®，规格：110 μg/50 μg，Siegfried Barbera, S.L.生产）在健康参与者体内的药代动力学特征，为正式人体生物等效性研究提供参考。

[Translation]

The pharmacokinetic characteristics of the test preparation, indacaterol bromide inhalation powder (specification: 110 μg/50 μg, produced by Jiangxi Aishite Pharmaceutical Co., Ltd.) and the reference preparation, indacaterol bromide inhalation powder (Jierun®, specification: 110 μg/50 μg, produced by Siegfried Barbera, S.L.), were studied in healthy participants after a single oral inhalation in the fasting state to provide a reference for the formal human bioequivalence study.

Start Date28 Aug 2025

Sponsor / Collaborator

Jiangxi Sinopharm Co., Ltd.

100 Clinical Results associated with Glycopyrrolate/Indacaterol Maleate

100 Translational Medicine associated with Glycopyrrolate/Indacaterol Maleate

100 Patents (Medical) associated with Glycopyrrolate/Indacaterol Maleate

Literatures (Medical) associated with Glycopyrrolate/Indacaterol Maleate

01 Oct 2025·Journal of Thoracic Disease

Efficacy, pharmacokinetics, and safety of nebulized HL231 inhalation solution in patients with chronic obstructive pulmonary disease: a randomized trial

Article

Author: Bian, Tao ; Xiong, Hao ; Li, Fangqiong ; Yue, Yun ; Xie, Lihua ; Li, Yaming ; Xiao, Zuke ; Hu, Qingyuan ; Yang, Guoping ; Zhao, Li ; Chen, Feng ; Wen, Fuqiang ; Luo, Zhu ; He, Qing ; Luo, Lin

Background:

Long-acting beta-agonist (LABA) plus long-acting muscarinic antagonist (LAMA) is superior to monotherapy or corticosteroid/LABA in terms of improving lung function, alleviating symptoms and educe chronic obstructive pulmonary disease (COPD) exacerbations. This study aimed to establish optimal dosage of nebulized HL231 inhalation solution (HL231), comparable to Ultibro^® (110 µg indacaterol maleate/50 µg glycopyrronium bromide), for bronchodilatation, pharmacokinetics, and safety in COPD.

Methods:

This study employed a multicenter, randomized, single-dose, single-blind, crossover design and featured two parts. The randomization schedule was generated by the statistical team using the block randomization procedure in SAS software. Chinese adults aged 40 years or older who were diagnosed with moderate-to-severe COPD using the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria were eligible for the study. Blinding was implemented for the personnel conducting pulmonary function tests. In Part A, patients were randomized to receive a single dose of HL231 (132 µg/72 µg, 261 µg/141 µg, or 516 µg/279 µg), Ultibro^®, or placebo in a randomized sequence with a washout period of at least 14 days between two visits. The primary efficacy endpoint was the change in the area under the curve (AUC) of FEV₁ from baseline to 12 h after administration (ΔFEV₁ AUC_0-12h). In Part B, patients were randomized to receive a single dose of HL231 (261 µg/120 µg and 261 µg/141 µg), or Ultibro^® in a randomized sequence. The primary endpoints were pharmacokinetic parameters, including the AUC from time 0 to the last detectable time point (AUC_0-t), AUC from time 0 to infinity (AUC_0-∞), and peak concentration (C_max). Safety was evaluated in both parts.

Results:

The study was initiated and completed between December 2021 and May 2023, with 173 and 29 patients screened in Part A and Part B respectively, resulting in 84 and 18 randomized patients, of whom 83 and 18 completed at least one treatment cycle. In Part A, the least squares (LS) mean differences in ΔFEV₁ AUC_0-12h for HL231 doses (132 µg/72 µg, 261 µg/141 µg, and 516 µg/279 µg) and Ultibro^® versus placebo were 2.30, 2.58, 2.68, and 2.33 L·h (all P<0.001), respectively, while compared to Ultibro^®, differences were -0.04 (P=0.83), 0.24 (P=0.14), and 0.35 L·h (P=0.04), respectively. Moreover, the LS means of ΔFEV₁ AUC0-12h for these doses were 2.30, 2.58, and 2.69 L·h, indicating a dose-response relationship. In Part B, HL231 261 µg/141 µg demonstrated peak concentration (C_max) of indacaterol and glycopyrronium at 86% and 54% of Ultibro^®, with comparable AUC_0-t. Safety was acceptable, with most treatment-emergent adverse events (TEAEs) being grade 1-2.

Conclusions:

HL231 (261 µg/141 µg) is highly comparable to Ultibro^® in bronchodilatation, pharmacokinetics, and safety, making it a potential alternative for COPD patients.

Trial Registration:

This study was registered at Chinese Clinical Trials Registration (ChiCTR2300068316) and clinicaltrials.gov (NCT06619210, retrospectively registered).

01 Feb 2024·International journal of pharmaceutics

Mixing energy as an adjustment tool for aerodynamic behaviour of an inhaled product: In-vitro and in-vivo effects

Article

Author: Merja Kirjavainen ; Ann-Marie Lyberg ; Laura Matilainen ; Stefan Göransson ; Kyrre Thalberg ; Elina Heinonen ; Satu Lähelmä ; Patrik Eriksson ; Maiju Autio ; Johanna Husman-Piirainen

This paper describes the development of a fixed dose dry powder combination of indacaterol maleate (Inda) and glycopyrronium bromide (Glyco) in Easyhaler® inhaler for a comparative pharmacokinetic (PK) study, as well as the outcome of such a study. The development aim was to produce formulations with three different in vitro dispersibility profiles for both Inda and Glyco. This so-called 'rake' approach allows for quantitation of the candidate formulations relative to the reference product Ultibro® Breezhaler® in terms of the key PK parameters. Three formulations (A, B and C) were produced based on the mixing energy concept. For both APIs, formulation A (lowest mixing energy) displayed the highest fine particle fractions and formulation C (highest mixing energy) the lowest. GMP manufacturing confirmed the performance of the three formulations. The candidate formulations were tested against the reference product in a single dose PK study in healthy volunteers. Clear differences in Inda plasma concentration profiles were observed between the treatments when administered concomitantly with charcoal, with Easyhaler A showing the highest C_max value and Easyhaler C the lowest. Easyhaler B was bioequivalent to Ultibro Breezhaler with regard to the primary PK parameters of Inda, C_max and AUC_72h. For Glyco, Easyhaler formulations A, B and C provided lower peak concentrations than Ultibro Breezhaler. For AUC_72h of Glyco_, Easyhaler B was bioequivalent to the reference product. Additional measures for adjustment of formulation performance can be foreseen, whose effects can be predicted based on mixing energy theory.

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).

News (Medical) associated with Glycopyrrolate/Indacaterol Maleate

07 Oct 2025

·www.businesswire.com

AeroRx Therapeutics Announces $21 Million Series A Financing to Advance Inhaled AERO-007, the First Nebulized LABA/LAMA for COPD, into Late-Stage Clinical Development

LA JOLLA, Calif.--(BUSINESS WIRE)--AeroRx Therapeutics, Inc., a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced the closing of a $21 million Series A financing led by Avalon BioVentures, with participation from Correlation Ventures, Alexandria Venture Investments, and others. Proceeds will support late-stage clinical development of AeroRx’s lead candidate, inhaled AERO-007, the first nebulized LABA/LAMA combination in development as a potential first-line maintenance therapy for chronic obstructive pulmonary disease (COPD). “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and CEO of AeroRx Therapeutics. Data from a completed Phase 2a clinical study of AERO-007 demonstrated that AERO-007 was well tolerated in patients with moderate to severe COPD, and provided rapid-onset, and clinically meaningful, sustained bronchodilation through 24 hours at both low and high doses. “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “Our Phase 2a study data further support AERO-007’s potential as a once-daily nebulized LABA/LAMA combination, designed to address a major unmet need for underserved COPD patients.” “Dual bronchodilation via handheld inhalers is the standard of care, but millions of patients remain poorly controlled due to difficulties with inhaler technique,” said Jay Lichter, Ph.D., Managing Partner at Avalon BioVentures. “AeroRx has the opportunity to deliver meaningful clinical benefit by bringing the preferred guideline therapy to patients in a nebulized form that is designed for full dosing and improved adherence.” The Phase 2a clinical trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover that enrolled 16 adults with moderate-to-severe COPD. Both the low- and high-dose treatments of AERO-007 delivered clinically meaningful, statistically significant improvements in forced expiratory volume in one second (FEV1, the standard efficacy parameter based on serial spirometry assessment) compared to placebo. Inhaled AERO-007 was well tolerated with a tolerability and systemic drug exposure profile comparable to the previously approved drugs with the individual active components. About AERO-007 AERO-007 combines the long-acting, FDA-approved bronchodilators indacaterol (LABA) and glycopyrrolate (LAMA) in a proprietary formulation for delivery via a 510(k)-cleared standard jet nebulizer. More than 16 million people in the United States are diagnosed with COPD, posing a significant economic and social burden, and as many as 50 percent remain symptomatic even while using FDA-approved LABA/LAMA maintenance therapy delivered via inhalers (1). Studies also show that up to 75 percent of patients do not receive the full therapeutic dose from handheld inhaler devices, which demand coordination and forceful inhalation (2). Nebulized delivery offers a passive-breathing alternative that can provide more consistent dosing for patients who find inhalers challenging, particularly older adults and those with advanced COPD, who are at high risk for exacerbations, hospitalization, and disease progression (3). References: (1) American Lung Association, accessed July 24, 2025; Boers et al. JAMA Network Open 2023; Molimard et al. Eur Respir J 2017 (2) Kocks et al. BMC Pulm Med 2023 (3) Crater et al. Ther Adv Respir Dis 2022; Barjaktarevic et al. Int J COPD 2020 About AeroRx Therapeutics AeroRx Therapeutics is a clinical-stage biopharmaceutical company developing proprietary, combination products for nebulized delivery to improve the treatment of chronic respiratory diseases. The company’s lead product candidate, inhaled AERO-007, is the first potential nebulized LABA/LAMA fixed-dose combination drug in clinical development as a potential first-line maintenance therapy for COPD and has the potential to help millions of patients who remain symptomatic, or poorly served, under existing drugs delivered via handheld inhalers or nebulized LABA or LAMA monotherapy. A second program, AERO-111, is in development as the first potential nebulized LABA/LAMA/ICS triple therapy, for patients who escalate beyond dual bronchodilators. AeroRx’s leadership team has decades of expertise in aerosol drug delivery, clinical development, and regulatory strategy and guided multiple respiratory therapies from concept to regulatory approval. AeroRx is headquartered in the Avalon BioVentures Accelerator in La Jolla, California. For more visit, www.aerorxtx.com.

Phase 2Clinical Result

07 Oct 2025

·endpoints.news

AeroRx closes $21M Series A in bid to capitalize on COPD momentum

A respiratory biotech that launched Tuesday morning aims to take advantage of excitement in COPD drug development spurred by two recent deals. AeroRx Therapeutics took the wraps off a $21 million Series A that it’s using to get its lead program through Phase 2b testing in chronic obstructive pulmonary disease, or COPD. It’s the same category that spurred Merck’s $10 billion acquisition of Verona Pharma and GSK’s partnership with Hengrui Pharma that could be worth $12 billion if everything pans out. The AeroRx drug, known as AERO-007, is a nebulized reformulation of two approved compounds — indacaterol and glycopyrrolate — that use different mechanisms of action. Indacaterol is a long-acting beta agonist (LABA), while glycopyrrolate is a long-acting muscarinic agonist (LAMA). Combining LABAs and LAMAs is common when treating COPD. AeroRx CEO Ahmet Tutuncu said the FDA has approved five such products. An inhaler combination of indacaterol and glycopyrrolate was approved in 2015 as Utibron, which was developed by Novartis and out-licensed to Sunovion Pharmaceuticals a year later. (Sunovion is now owned by Sumitomo Pharma.) All the approvals are for inhalers with dry powder, which is more difficult for older and sicker patients to use, Tutuncu said. AeroRx believes it can be the first company to offer a nebulized formulation as a first-line maintenance therapy in COPD. “It’s a different delivery technology, or full dose delivery, for those patients who need to be on nebulized medicines,” Tutuncu said. “A significant number of COPD patients who are typically getting older, they are on inhalers, but they are the ones who end up in hospitals with exacerbations for symptom control, and therefore they need to be on nebulized medicine.” So far, AeroRx has run a small Phase 2a study with 16 patients that suggested AERO-007 could be dosed once daily. In the Phase 2b trial, researchers plan to test once-daily and twice-daily doses. Most other details about the trial remain undisclosed until after discussions with the FDA, according to Tutuncu, including how long it’s expected to last. But because both components of AERO-007 are already approved, Tutuncu expects an “abbreviated” late-stage development process comprising the Phase 2b and Phase 3 trials. The trials will also enroll all COPD patients, and if AERO-007 wins approval, AeroRx plans to market it for patients older than 65 years old. The company also has another preclinical program called AERO-111, which is a triple combination nebulized COPD treatment. (There are two approved triple-combo inhalers.) In addition to a LABA and LAMA compound, AERO-111 also includes a corticosteroid. Tutuncu said the company is still figuring out which one to use. AeroRx’s Series A comes about 18 months after it closed a $6 million seed round in the spring of last year. With the new cash in hand, AeroRx is aiming to capitalize on the recent momentum in COPD following the Merck and GSK deals. “Those were two really important validation points for the interest from big pharma for nebulized delivery in the respiratory space, and particularly in the COPD space,” Tutuncu said. “We’re very excited about that potential for collaboration with pharma down the road.”

Phase 2Drug ApprovalAcquisition

07 Oct 2025

·firstwordpharma.com

AeroRx raises $21M for mid-stage study of nebulised COPD treatment

Two months after posting proof-of-concept data supporting its nebulised approach to treating chronic obstructive pulmonary disease (COPD), AeroRx Therapeutics has bagged a $21-million series A to kick off a Phase IIb trial of AERO-007.The biotech's candidate is poised to become the first nebulised combination of a long-acting beta agonist (LABA) and a long-acting muscarinic antagonist (LAMA) for first-line maintenance treatment of COPD, CEO Ahmet Tutuncu told FirstWord. While dual LABA/LAMA bronchodilation delivered via handheld inhaler is the standard first-line therapy, a subset of patients with COPD can't effectively use the devices, or prefer nebulised treatments, he explained."Up to 75% of COPD patients, particularly older and sicker individuals, do not receive the optimal dose from inhalers, leading to poor symptom control, more frequent exacerbations, and hospitalisations," Tutuncu said. "By contrast, nebulised delivery is designed to provide the full intended dose regardless of disease severity or patient technique, using normal, passive breathing. This ensures more consistent drug delivery, improves adherence, and gives the patients and clinicians greater confidence that patients are receiving effective therapy."However, there are no approved nebulised LABA/LAMA combinations — and that's where AeroRx and AERO-007 come in. In July, the company reported results from a Phase IIa study showing that in 16 adults with moderate-to-severe COPD, both low- and high-doses of AERO-007 led to clinically meaningful, statistically significant improvements in forced expiratory volume in one second compared with placebo, with rapid-onset and sustained 24-hour bronchodilation.Additionally, the treatment was well tolerated, with a systemic drug exposure profile similar to that of other LABAs and LAMAs. With the proceeds from the series A — led by Avalon BioVentures, with participation from Correlation Ventures and Alexandria Venture — AeroRx plans to launch a Phase IIb dose-optimisation study in early 2026. The 14-day, placebo-controlled crossover study will randomise patients with COPD to evaluate once- versus twice-daily dosing, and to select the dosage of AERO-007 for Phase III testing. "Our goal has always been simple: ensure that every patient can receive the best-in-class treatment their condition demands, regardless of their ability to use an inhaler," Tutuncu said. "This financing moves us closer to that vision."

Phase 2Clinical Result

100 Deals associated with Glycopyrrolate/Indacaterol Maleate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Glycopyrrolate/Indacaterol Maleate	R03AL04	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Airway Obstruction	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Bronchitis, Chronic	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Emphysema	United States	Novartis Pharmaceuticals Corp.	29 Oct 2015
Pulmonary Disease, Chronic Obstructive	European Union	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Iceland	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Liechtenstein	Novartis Europharm Ltd.	18 Sep 2013
Pulmonary Disease, Chronic Obstructive	Norway	Novartis Europharm Ltd.	18 Sep 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dyspnea	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Canada	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	Spain	Novartis Pharmaceuticals Corp.	01 Oct 2011
Dyspnea	Phase 3	United Kingdom	Novartis Pharmaceuticals Corp.	01 Oct 2011

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01782326 (FLAME, Pubmed \| Thorax)	Phase 3	Pulmonary Disease, Chronic Obstructive	3,362	Indacaterol Glycopyrronium	ugdxysqroo(roxzpuvgti): RR = 2.2 (95.0% CI, 1.2 - 4.1), P-Value = 0.001 View more	Positive	15 Dec 2025
				Fluticasone Salmeterol
ATS2025	Not Applicable	Pulmonary Disease, Chronic Obstructive	191	Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 µg	uazeobkzxh(iqikfrqnsi) = mqtoyaovns luvsacczpp (qrxbxyisbl, 105 - 180)	Positive	16 May 2025
NCT02867761 (RETHINC, CTgov)	Phase 3	Pulmonary Disease, Chronic Obstructive	780	Indacaterol/Glycopyrrolate (Indacaterol/Glycopyrrolate)	nzhonxgexe = kkocraughi lvwmviaork (vuawjgxyyp, pknhgxbioy - dzksvlqzzs) View more	-	30 Aug 2022
				Placebo (Placebo)	nzhonxgexe = qjjmzemakb lvwmviaork (vuawjgxyyp, amrxifikia - nozuoanexd) View more
NCT02566031 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	379	Indacaterol and glycopyrronium (QVA149) (Indacaterol and Glycopyrronium (QVA149))	wvnpnambjl(glaipobfee) = mlaprcolha rnrahxmdod (uffcjvyoso, 0.18097) View more	-	23 Sep 2019
				Tiotropium (Tiotropium)	wvnpnambjl(glaipobfee) = ugjdkzfvxw rnrahxmdod (uffcjvyoso, 0.18487) View more
NCT02202616 (POWER, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	401	Sal+Flu+QVA149 (QVA149 110/50 After Flu/Sal)	mhuhhqszqk(raywynfrpb) = payvxshfaj gzhenegtfl (lenxvavgvc, 0.397) View more	-	24 Jun 2019
				QVA149 (QVA149 110/50 After Tio)	mhuhhqszqk(raywynfrpb) = fwctywuicw gzhenegtfl (lenxvavgvc, 0.321) View more
NCT02634983 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	31	QVA149 (QVA149 110/50 mcg)	kffdiwetgr(ftasmflckk) = fwrlqfzrrq evkbawiljo (mbambxifdl, xtgoubwtip - zduccygivb) View more	-	03 Jun 2019
				placebo (Matching Placebo)	kffdiwetgr(ftasmflckk) = kmfbmtlabc evkbawiljo (mbambxifdl, byrunkgupe - ptwtakazhf) View more
NCT02442206 (CLAIM, Pubmed \| Am J Respir Crit Care Med)	Phase 4	Pulmonary Disease, Chronic Obstructive	62	Indacaterol/Glycopyrronium	zlfxabsviv(lgcphejrfw) = gjknxpywic dynvltkzpy (xazhpvfrgx )	-	01 May 2019
NCT02603393 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	1,053	QVA149 (QVA149)	vqipcvbtky(tabxnpaoih) = wjzlngjwzv vnxyebtfsq (yqdgrpshea, 0.0119) View more	-	29 Apr 2019
				Tiotropium+Salmeterol/fluticasone (Tiotropium + Salmeterol/Fluticasone)	vqipcvbtky(tabxnpaoih) = gjkowvusod vnxyebtfsq (yqdgrpshea, 0.0115) View more
NCT02516592 (FLASH, CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	500	QVA149 110/50 micrograms (QVA149 110/50 Micrograms)	ciexlwmtbw(vcewsdobjq) = qwymbsrbkk bmypjyamhn (cnpqzlnjqf, 0.0151) View more	-	21 Mar 2019
				Salmeterol/fluticasone 50/500 microgrammes (Salmeterol/Fluticasone 50/500 Micrograms)	ciexlwmtbw(vcewsdobjq) = bjleoveunq bmypjyamhn (cnpqzlnjqf, 0.0152) View more
NCT02233543 (CTgov)	Phase 4	Pulmonary Disease, Chronic Obstructive	38	Indacaterol+Glycopyrronium+QVA149 (QVA149 (Indacaterol/Glycopyrronium))	ylpjsrirlt(vcfgivcjqx) = vmftihzphp tvxadtijue (ytcxlfqijk, 0.30) View more	-	06 Aug 2018
				QVA149 (Placebo)	ylpjsrirlt(vcfgivcjqx) = buyxiqdqrd tvxadtijue (ytcxlfqijk, 0.28) View more

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis