Evidence map›Paper›PMID 27126725›Full record

ArticleAllergy, asthma & immunology research2016

Omalizumab Improves Quality of Life and Asthma Control in Chinese Patients With Moderate to Severe Asthma: A Randomized Phase III Study.

Jing Li, Jian Kang, Changzheng Wang, Jing Yang, Linda Wang, Ioannis Kottakis, Michael Humphries, Nanshan Zhong, China Omalizumab Study Group

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Allergy, asthma & immunology research, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 4 pooled it
3.5field-weighted citation impact, top 8% of its field
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

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

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

27 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Biologic agents licensed for severe asthma: a systematic review and meta-analysis of randomised controlled trials.European respiratory review : an official journal of the European Respiratory Society · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 2 countries.

Jing LiState Key Laboratory of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.
Jian KangInstitute of Respiratory Disease, First Hospital of China Medical University, Shenyang, China.
Changzheng WangInstitute of Respiratory Disease, Xinqiao Hospital, Third Military Medical University, Chongqing, China.
Jing YangRespiratory Franchise, Beijing Novartis Pharma Co. Ltd., Beijing, China.
Linda WangIQS, Beijing Novartis Pharma Co. Ltd., Shanghai, China.
Ioannis KottakisNovartis Pharma AG, Basel, Switzerland.
Michael HumphriesRespiratory Franchise, Beijing Novartis Pharma Co. Ltd., Beijing, China.
Nanshan ZhongState Key Laboratory of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China. nanshan@vip.163.com.
China Omalizumab Study Group
Novartis (China) · CNFirst Affiliated Hospital of Guangzhou Medical University · CNFirst Hospital of China Medical University · CNNovartis (Switzerland) · CHXinqiao Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeOmalizumab is the preferred add-on therapy for patients with moderate-to-severe persistent allergic asthma and has demonstrated efficacy and safety in various ethnicities. This study evaluated the efficacy and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma.

methodsThis randomized, double-blind, parallel-group, placebo-controlled, phase III study assessed lung function, quality of life, asthma control, and safety of omalizumab after 24-week therapy in Chinese patients (18-75 years of age).

resultsA total of 616 patients were randomized (1:1) to omalizumab or placebo. The primary endpoint, least squares mean treatment difference (LSM-TD) in morning peak expiratory flow (PEF) (omalizumab vs placebo), at Weeks >20-24 was 8.85 L/min (Full analysis set; P=0.062). Per-protocol analysis set showed significant improvements with LSM-TD of 11.53 L/min in mean mPEF at Weeks >20-24 (P=0.022). The FEV1 % predicted was significantly improved with omalizumab vs placebo from 8 to 24 weeks (after 24-week treatment: LSM-TD=4.12%; P=0.001). At Week 24, a higher proportion of omalizumab-treated patients achieved clinically relevant improvements in standardized AQLQ (58.2% vs 39.3%; LSM=0.51 vs 0.10; P<0.001) and ACQ (49.5% vs 35.5%; LSM=-0.51 vs -0.34; P=0.002) scores vs placebo. Total and nighttime symptom scores reduced significantly with omalizumab vs placebo (LSM-TD=-0.21, P=0.048 and -0.12, P=0.011, respectively). Although the study was not powered to study differences in exacerbation rates (P=0.097), exacerbations in winter months were less frequent in the omalizumab vs placebo group (2 vs 21). Adverse event and severe adverse event rates were comparable between omalizumab and placebo.

conclusionsOmalizumab improves lung function, quality of life, and asthma control in Chinese patients with moderate-to-severe persistent allergic asthma and has a good safety profile.

Indexed as

allergy and immunologyAsthmaChinaomalizumabquality of life

Identifiers

PMID27126725
PMCPMC4853509
OpenAlexW2342660048

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

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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.