更新于：2024-11-01

Zydus Healthcare Ltd.

子公司|

India

子公司|

India

更新于：2024-11-01

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项与 Zydus Healthcare Ltd. 相关的临床试验

CTRI/2024/02/063046 / Recruiting临床3期

A prospective, randomized, parallel, activecontrolled,multicentre, phase III clinical trial toassess the efficacy and safety of Vilanterol,Glycopyrronium and Fluticasone furoatepowder for inhalation as compared toIndacaterol, Glycopyrronium and Mometasonefuroate powder for inhalation in patients withpersistent asthma - Nil

开始日期2024-03-05

申办/合作机构

Zydus Healthcare Ltd.

CTRI/2024/01/061230 / Active, not recruiting临床3期

A prospective, randomized, parallel, active controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol, Glycopyrronium and Fluticasone furoate inhalation as compared to Indacaterol, Glycopyrronium and Mometasone furoate inhalation in patients with persistent asthma - Nil

开始日期2024-01-15

申办/合作机构

Zydus Healthcare Ltd.

CTRI/2023/08/056077 / RecruitingN/A

Real World Evidence on safety and effectiveness of single inhaler triple-therapy(glycopyrrolate/formoterol fumarate/budesonide) in patients with COPD - NIL

开始日期2023-08-10

申办/合作机构

Zydus Healthcare Ltd.

100 项与 Zydus Healthcare Ltd. 相关的临床结果

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0 项与 Zydus Healthcare Ltd. 相关的专利（医药）

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项与 Zydus Healthcare Ltd. 相关的文献（医药）

2024-10-02·Journal of Asthma

Efficacy and safety of Once-Daily Vilanterol/Fluticasone furoate MDI in persistent asthma: Phase 3 OD-INHALE Study

Article

作者: Jain, Manish Kumar ; Mehta, Ravi T. ; Kumar, Raghumanda Sunil ; Mondal, Asish ; Barge, Vijaykumar Bhagwan ; Yadav, Harendra ; Redkar, Vivek Eknath ; Gupta, Neeraj ; Kumar, Avdhesh ; Pal, Amitava ; Rathore, Rahul Kumar ; Jaiswal, Ashok ; Daultani, Pavankumar

INTRODUCTIONOnce-daily inhalers have been shown to improve adherence leading to lesser discontinuation compared to twice- or thrice-daily inhalers in management of asthma. Combination of Vilanterol and Fluticasone Furoate (VI/FF) is approved for management of asthma and COPD and is available as a dry powder inhaler. Pressurized-Metered Dose Inhalers (pMDIs) offer ease-of-use and therapy alternatives for patients with low inspiratory flow. This study assessed the efficacy and safety of a new once-daily pMDI containing VI/FF in individuals diagnosed with persistent asthma.METHODSThis phase 3, double-blind, randomized controlled study assessed the non-inferiority of VI/FF (12.5 mcg/50 mcg & 12.5 mcg/100 mcg; 2 puffs once-daily) over Formoterol Fumarate and Fluticasone Propionate (FOR/FP, 6 mcg/125 mcg & 6 mcg/250 mcg; 2 puffs twice-daily) in patients with persistent asthma. Primary outcome was change from baseline in trough FEV1 at the end of study (12 weeks). Adverse events and number of exacerbations were used to evaluate safety.RESULTSA total of 330 patients were randomized into VI/FF (165) and FOR/FP (165). Trough FEV1 significantly improved in both the groups at week 12, with a mean difference (VI/FF minus FOR/FP) being 54.75 mL (95% CI, 8.42-101.08 mL, p = 0.02). The low dose VI/FF had similar efficacy to that of low dose FOR/FP and high dose VI/FF had similar efficacy to high dose FOR/FP. No serious adverse events were reported during the study.CONCLUSIONOnce daily VI/FF pMDI was non-inferior to twice daily FOR/FP pMDI in patients with persistent asthma.

2024-09-28·IP Indian Journal of Clinical and Experimental Dermatology

A real-world observational study to evaluate the safety & effectiveness of Naftifine 2% cream in patients with superficial fungal skin infection

作者: Chinda, Monika ; Raj, Chinmoy ; Godse, Kiran ; Jaiswal, Ashok D ; Bhaskar, Gaurav ; Adhikari, Pankaj ; Prasad, AK ; Mapare, Arjun ; Vidya, T S

Naftifine hydrochloride, an allylamine, is a topical agent used in treating superficial fungal infections, especially dermatophytosis. The objective of this study was to assess the safety and effectiveness of naftifine 2% cream in Indian patients with superficial fungal skin infection. A real-world observational study to evaluate the safety & effectiveness of Naftifine 2% cream in patients with superficial fungal skin infection.It was an open-label, multi-centric, observational, prospective real-world study conducted on Indian patients, where subjects were advised to apply naftifine 2% cream on the affected area at the discretion of the treating physician. Effectiveness was determined by assessing the clinical cure (absence of signs and symptoms) and/or mycological cure (negative microscopic KOH test) at the end of the treatment. Safety & tolerability were evaluated based on the presence of adverse events and their severity. The patient compliance was recorded based on the investigator's assessment.A total of 463 patients were enrolled in the study, out of which 82.07% achieved a clinical cure at the end of the treatment. The skin scraping for microscopic KOH mounting was available for 94 patients out of which the mycological cure was observed in 89 patients (94.6%) (p<0.0001) at the end of the treatment. Our study recorded a lower incidence of adverse events (2.4%), commonly including dermatitis, pruritis, skin irritation at the application site, and erythema. The reported adverse events were mild or moderate and were cured within 2-7 days. The naftifine 2% cream was well tolerated by 70.8% of the patients. Upon completion of the treatment, 296 patients (64.1%) exhibited 100% compliance to the study drug.Topical Naftifine 2% cream was safe and effective in Indian patients with tinea cruris and tinea corporis.

2024-05-12·Cureus

Efficacy and Safety of Amorolfine Lotion 0.25% w/v Compared to Amorolfine Cream 0.25% w/w in Patients With Superficial Fungal Infections of the Skin: A Multi-center, Randomized, Open-Label, Active-Controlled, Non-inferiority Phase III Clinical Trial

Article

作者: Mittal, Ravindra ; Kumar, Surendra ; Siddananjappa, Lokesh ; Chinda, Monika ; Sidana, Neetu ; Jaiswal, Ashok ; Daultani, Pavankumar ; Rao, M Kanaka Prasad ; Podder, Indrasish ; Diwari, Binayak ; Deshmukh, Ashish

BACKGROUNDDermatophytosis, a major cause of superficial fungal infections, requires topical and systemic antifungals. Amorolfine, a morpholine derivative, is a new topical antifungal available in cream and lotion formulations.OBJECTIVETo evaluate the efficacy and safety of amorolfine lotion 0.25% compared to amorolfine cream 0.25% in patients with dermatophytosis.METHODSA multi-center randomized, two-arm, active-controlled, parallel, non-inferiority phase III clinical trial involving 284 dermatophytosis patients was conducted, with the test arm using amorolfine lotion and the reference arm using amorolfine cream. The study drugs were applied once daily in the evening for four weeks and patients were followed up for another two weeks. The primary endpoint was clinical cure, while secondary endpoints included mycological cure, composite cure, global efficacy assessment, and post-treatment relapse. Safety and tolerability were assessed.RESULTSAmongst the enrolled patients, 69.9% and 68.1% of patients had tinea corporis, while 30.1% and 31.9% had tinea cruris. The majority of patients in both groups (99.3% test and 97% reference) achieved a clinical cure at the end of treatment. Mycological cure was achieved by 98.6% and 96.3% respectively. A composite cure was achieved by 98.6% in the test arm versus 96.3% in the reference arm. A total of two AEs were reported in two (1.4%) patients in the test group and three AEs were reported in three (2.1%) patients in the reference group, all of the AEs were mild and resolved within three days without supportive medication. No severe adverse effects were reported in any of the study subjects.CONCLUSIONAmorolfine lotion 0.25% w/v showed a non-inferior clinical, mycological, and composite cure in dermatophytosis patients, was well-tolerated, and had a similar safety profile to amorolfine cream 0.25% w/w.

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100 项与 Zydus Healthcare Ltd. 相关的转化医学

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