Evidence map›Paper›PMID 33277507›Full record

Trial reportNPJ primary care respiratory medicine2020

Long-term safety of tiotropium/olodaterol in older patients with moderate-to-very-severe COPD in the TONADO® studies.

Gary T Ferguson, François Maltais, Jill Karpel, Ulrich Bothner, Isabel Kloer, Matthias Trampisch, Roland Buhl

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in NPJ primary care respiratory medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
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

7 authors at 4 institutions in 3 countries.

Gary T FergusonPulmonary Research Institute of Southeast Michigan, 29255 West 10 Mile Road, Suite A, Farmington Hills, MI, 48336, USA. garytferguson@msn.com.ORCID 0000-0002-3277-4110
François MaltaisCentre de Recherche, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laal, 2725 Chemin Sainte-Foy, Québec City, QC, G1V 4G5, Canada.
Jill KarpelNorth Shore Medical Arts LLP, 295 Community Drive, Great Neck, New York, NY, 11021, USA.
Ulrich BothnerBoehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.ORCID 0000-0001-6515-0841
Isabel KloerBoehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.
Matthias TrampischBoehringer Ingelheim International GmbH, Binger Strasse 173, D-55216, Ingelheim am Rhein, Germany.
Roland BuhlPulmonary Department, Johannes Gutenberg University Mainz, Langenbeckstrasse 1, D-55131, Mainz, Germany.
Boehringer Ingelheim (Germany) · DEInstitut universitaire de cardiologie et de pneumologie de Québec · CAJohannes Gutenberg University Mainz · DEMichigan Surgical Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Older patients with chronic obstructive pulmonary disease (COPD) may be at increased risk of adverse events (AEs) due to decreased protective organ function and increased comorbidities. TONADO® 1 + 2 were replicate, randomized, double-blind, parallel-group, 52-week, Phase III trials comparing the efficacy and safety of tiotropium/olodaterol (5/5 µg) versus the monocomponents via the Respimat® inhaler in patients with moderate-to-very-severe COPD. In this prespecified safety analysis, patients were grouped by age. Of 3100 patients, 1585 (51.1%) were aged <65 years, 1198 (38.7%) 65-<75 years, 309 (10.0%) 75-<85 years, and eight (0.3%) ≥85 years. At baseline, 23.4% had a pre-existing cardiac disorder, 45.6% had hypertension, and 13.3% had glucose metabolism disorders, including diagnosed diabetes. Overall, there was no increase in major adverse cardiac events, other AEs, or serious AEs with tiotropium/olodaterol versus the monocomponents in any age group, supporting the safety of tiotropium/olodaterol in older patients with COPD.

Indexed as

AgedAged, 80 and overAge FactorsBenzoxazinesBronchodilator AgentsDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveSeverity of Illness IndexTiotropium BromideTreatment OutcomeBenzoxazinesBronchodilator AgentsDrug CombinationsTiotropium Bromidetiotropium-olodaterol

Identifiers

PMID33277507
PMCPMC7719164
OpenAlexW3109042046

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.