Evidence map›Paper›PMID 25894430›Full record

Trial reportPloS one2015

Long-Term Once-Daily Tiotropium Respimat® Is Well Tolerated and Maintains Efficacy over 52 Weeks in Patients with Symptomatic Asthma in Japan: A Randomised, Placebo-Controlled Study.

Ken Ohta, Masakazu Ichinose, Yuji Tohda, Michael Engel, Petra Moroni-Zentgraf, Satoko Kunimitsu, Wataru Sakamoto, Mitsuru Adachi

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01340209 (A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler), which is not on this map. Cited by 36 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 8 pooled it
7.5field-weighted citation impact, top 2% 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.

NCT01340209 phase3completednot on this map

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 µg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled285ConditionsAsthmaArmsTiotropium Respimat, Placebo Respimat
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 8 syntheses or guidelines pooled it, 89 citations in OpenAlex.

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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

8 authors at 6 institutions in 2 countries.

Ken OhtaNational Hospital Organization, Tokyo National Hospital, Tokyo, Japan.
Masakazu IchinoseDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yuji TohdaDepartment of Respiratory Medicine and Allergology, Kinki University, Faculty of Medicine, Osakasayama City, Japan.
Michael EngelTA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Petra Moroni-ZentgrafTA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Satoko KunimitsuClinical Trial Management Department, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Wataru SakamotoMedical Data Services Department, Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.
Mitsuru AdachiDepartment of Clinical Research Center, International University of Health and Welfare, Sanno Hospital, Tokyo, Japan.
Boehringer Ingelheim (Germany) · DEBoehringer Ingelheim (Japan) · JPInternational University of Health and Welfare · JPKindai University · JPTohoku University · JPTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study assessed the long-term safety and efficacy of tiotropium Respimat, a long-acting inhaled anticholinergic bronchodilator, in asthma, added on to inhaled corticosteroids (ICS) with or without long-acting β2-agonist (LABA).

methods285 patients with symptomatic asthma, despite treatment with ICS±LABA, were randomised 2:2:1 to once-daily tiotropium 5 μg, tiotropium 2.5 μg or placebo for 52 weeks (via the Respimat SoftMist inhaler) added on to ICS±LABA, in a double-blind, placebo-controlled, parallel-group study (NCT01340209). PRIMARY

objectiveto describe the long-term safety profile of tiotropium. Secondary end points included: trough forced expiratory volume in 1 second (FEV1) response; peak expiratory flow rate (PEFR) response; seven-question Asthma Control Questionnaire (ACQ-7) score.

resultsAt Week 52, adverse-event (AE) rates with tiotropium 5 μg, 2.5 μg and placebo were 88.6%, 86.8% and 89.5%, respectively. Commonly reported AEs with tiotropium 5 μg, 2.5 μg and placebo were nasopharyngitis (48.2%, 44.7%, 42.1%), asthma (28.9%, 29.8%, 38.6%), decreased PEFR (15.8%, 7.9%, 21.1%), bronchitis (9.6%, 13.2%, 7.0%), pharyngitis (7.9%, 13.2%, 3.5%) and gastroenteritis (10.5%, 3.5%, 5.3%). In the tiotropium 5 μg, 2.5 μg and placebo groups, 8.8%, 5.3% and 5.3% of patients reported drug-related AEs; 3.5%, 3.5% and 15.8% reported serious AEs. Asthma worsening was the only serious AE reported in more than one patient. At Week 52, adjusted mean trough FEV1 and trough PEFR responses were significantly higher with tiotropium 5 μg (but not 2.5 μg) versus placebo. ACQ-7 responder rates were higher with tiotropium 5 μg and 2.5 μg versus placebo at Week 24.

conclusionsThe long-term tiotropium Respimat safety profile was comparable with that of placebo Respimat, and associated with mild to moderate, non-serious AEs in patients with symptomatic asthma despite ICS±LABA therapy. Compared with placebo, tiotropium 5 μg, but not 2.5 μg, significantly improved lung function and symptoms, supporting the long-term efficacy of the 5 μg dose.

trial registrationClinicalTrials.gov NCT01340209.

Indexed as

Administration, InhalationAdolescentAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAdultAgedAsthmaBronchodilator AgentsCholinergic AntagonistsDouble-Blind MethodDrug Administration ScheduleFemaleForced Expiratory VolumeHumansJapanMaleAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsCholinergic AntagonistsTiotropium Bromide

Identifiers

PMID25894430
PMCPMC4404354
OpenAlexW2071270488

What OpenQuestion holds

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Registered trials

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.