Evidence map›Paper›PMID 39996620›Full record

Observational studyAdvances in respiratory medicine2025

Prospective, Open-Label, Observational, Multicenter, Single Arm, Post-Marketing Study in Asthmatic Patients for Evaluation of Safety and Effectiveness of Indacaterol/Mometasone DPI (PROMISING-SHIFT).

Saurabh Karmakar, Gajendra V Singh, Amit S Bhate, Vijaykumar Barge, Bharat Mehrotra, Chintan Patel, Ekta Sinha, Sagar Bhagat, Saiprasad Patil, Hanmant Barkate

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Advances in respiratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

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5 · Who and what money

Authors and funding

10 authors.

Saurabh KarmakarDepartment of Pulmonary Medicine, All India Institute of Medical Sciences, Patna 801507, India.
Gajendra V SinghDepartment of Pulmonary Medicine, Sarojini Naidu Medical College, Agra 282003, India.
Amit S BhateDepartment of Pulmonary Medicine, Jeevan Rekha Hospital, Belagavi 590010, India.
Vijaykumar BargeDepartment of Medicine, Chhatrapati Pramilaraje Hospital, Kolhapur 416012, India.
Bharat MehrotraDepartment of Pulmonary Medicine, New Leelamani Hospital Pvt Ltd., Kanpur 208001, India.
Chintan PatelDepartment of Pulmonary Medicine, Aatman Hospital, Ahmedabad 380058, India.
Ekta SinhaGlobal Medical Affairs, Glenmark Pharmaceutical Limited, Mumbai 400099, India.
Sagar BhagatGlobal Medical Affairs, Glenmark Pharmaceutical Limited, Mumbai 400099, India.
Saiprasad PatilGlobal Medical Affairs, Glenmark Pharmaceutical Limited, Mumbai 400099, India.
Hanmant BarkateGlobal Medical Affairs, Glenmark Pharmaceutical Limited, Mumbai 400099, India.

Funding

Glenmark Pharmaceuticals (India) na
6 · The paper itself

Abstract

backgroundAsthma significantly impacts global health, necessitating effective management strategies. A combination of inhaled corticosteroids (ICSs) and long-acting β2-agonists (LABA) is recommended for patients with inadequately controlled asthma.

methodThis prospective, open-label, multicenter study (PROMISING-SHIFT) study evaluated the safety and efficacy of once-daily Indacaterol/Mometasone (IND/MF) dry powder inhaler (DPI) in Indian asthma patients (≥12 years), inadequately controlled with prior therapies. Patients received IND/MF DPI in three strengths (150/80 mcg, 150/160 mcg, 150/320 mcg) over 12 weeks.

resultsThe study included a total of 174 participants, and 27 adverse events (AEs) in 25 patients (14.37%) were reported, primarily mild to moderate, with no serious adverse events (SAEs). Drug-related treatment-emergent adverse events (TEAEs) were observed in 11 patients. Significant improvements were noted in the mean trough FEV1 and FVC, increasing from baseline to week 4 and week 12 (

conclusionOnce-daily IND/MF DPI demonstrated a favorable safety profile with marked improvements in lung function, asthma control, and patient satisfaction, making it a promising option for long-term asthma management in Indian patients.

Indexed as

AsthmaIndansMometasone FuroateQuinolonesAdministration, InhalationAdultAgedDrug CombinationsDry Powder InhalersFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingProspective StudiesTreatment OutcomeDrug CombinationsIndansMometasone FuroateQuinolonesasthmaIndacaterol/Mometasoneinhaled corticosteroidsLABA

Identifiers

PMID39996620
PMCPMC11852356

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.