Evidence map›Paper›PMID 33731991›Full record

Observational studyInternational journal of chronic obstructive pulmonary disease

Therapeutic Success of Tiotropium/Olodaterol, Measured Using the Clinical COPD Questionnaire (CCQ), in Routine Clinical Practice: A Multinational Non-Interventional Study.

Arschang Valipour, Sergey Avdeev, Adam Barczyk, Valentina Bayer, Zvi Fridlender, Mariela Georgieva, Ondřej Kudela, Alexey Medvedchikov, Ramona Miron, Maria Sanzharovskaya and 4 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03663569 (Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 26% 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.

NCT03663569 completednot on this map

Changes in Clinical Control of COPD Patients Measured by the Clinical COPD Questionnaire During Therapy With Spiolto®Respimat® in Routine Clinical Practice

TypeobservationalSponsorBoehringer IngelheimRan2018 to 2019Enrolled4,819ConditionsPulmonary Disease, Chronic ObstructiveArmsSpiolto® Respimat®
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Long-acting muscarinic antagonist and long-acting βTherapeutic advances in respiratory disease
    Review
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

14 authors at 12 institutions in 12 countries.

Arschang ValipourDepartment of Respiratory and Critical Care Medicine, Karl-Landsteiner-Institute for Lung Research and Pulmonary Oncology, Vienna Health Care Group, Klinik Floridsdorf, Vienna, Austria.
Sergey AvdeevI.M. Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.ORCID 0000-0002-5999-2150
Adam BarczykWydział Nauk Medycznych Śląskiego Uniwersytetu Medycznego, Katowice, Poland.
Valentina BayerBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Zvi FridlenderHadassah-Hebrew University Medical Center, Jerusalem, Israel.ORCID 0000-0002-6122-1988
Mariela GeorgievaMedical Center "Sv.ivan Rilski" OOD, Vidin, Bulgaria.
Ondřej KudelaDepartment of Pneumology, Faculty of Medicine in Hradec Kralove, University Hospital Hradec Kralove, Charles University in Prague, Hradec Kralove, Czech Republic.
Alexey MedvedchikovBoehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.ORCID 0000-0001-8134-454X
Ramona MironClinical Pneumophtysiology Hospital Iasi, Iasi, Romania.
Maria SanzharovskayaBoehringer Ingelheim RCV GmbH & Co. KG, Vienna, Austria.
Virginija ŠileikienėFaculty of Medicine, Clinic of Chest Diseases, Immunology and Allergology, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania.
Jurij ŠorliBolnišnica Topolšica, Topolšica, Slovenia.
Marc SpielmannsZürcher RehaZentrum Wald, Wald, Switzerland.
Zsuzsanna SzalaiPetz Aladar County Teaching Hospital, Gyor, Hungary.ORCID 0000-0001-7012-2060
Boehringer Ingelheim (Austria) · ATBoehringer Ingelheim (United States) · USCharles University · CZClinica de Pneumologie Iaşi · ROGórnośląskie Centrum Medyczne · PLHadassah Medical Center · ILPetz Aladár Megyei Oktató Kórház · HUSechenov University · RUSplošna Bolnišnica Celje · SIUniversity Hospital St. Ivan Rilski · BGVilnius University · LTZürcher RehaZentrum Davos · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe Clinical COPD Questionnaire (CCQ) is a simple patient-reported tool to measure clinical control of chronic obstructive pulmonary disease (COPD).

objectiveThis open-label, single-arm, non-interventional study (NCT03663569) investigated changes in CCQ score during treatment with tiotropium/olodaterol in clinical practice.

methodsData were included from consenting COPD patients, enrolled in Bulgaria, Czech Republic, Hungary, Israel, Lithuania, Poland, Romania, Russia, Slovenia, Switzerland and Ukraine, who were receiving a new prescription for tiotropium/olodaterol according to the treating physician in a real-world environment. The primary endpoint was the occurrence of therapeutic success, defined as a 0.4-point decrease in CCQ score after treatment with tiotropium/olodaterol for approximately 6 weeks.

resultsOverall, 4819 patients were treated; baseline and Week 6 CCQ scores were available for 4700 patients, mostly classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) B (51.6%) or D (42.7%). After 6 weeks' treatment, 81.4% (95% confidence interval [95% CI] 80.24-82.49) of patients achieved therapeutic success; mean improvement in overall CCQ score was 1.02 points (95% CI 1.00-1.05). Improved CCQ score was seen in 92.2% of patients (95% CI 91.43-92.98), 2.5% had no change and 5.3% showed a worsening. When stratified by prior treatment, the greatest benefit was seen in treatment-naïve patients, with 85.7% achieving therapeutic success, compared with 79.5% of those pretreated with long-acting β

conclusionIn 4700 COPD patients, 6 weeks' treatment with tiotropium/olodaterol, as initial treatment or follow-up to LAMA or LABA monotherapy or LABA/ICS, improved CCQ and decreased rescue medication use. The adverse event profile was consistent with the known safety profile of tiotropium/olodaterol.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenergic beta-2 Receptor AgonistsBenzoxazinesBronchodilator AgentsBulgariaCzech RepublicDrug CombinationsHumansHungaryIsraelMuscarinic AntagonistsPolandRomaniaRussiaSurveys and QuestionnairesAdrenergic beta-2 Receptor AgonistsBenzoxazinesBronchodilator AgentsDrug CombinationsMuscarinic AntagonistsolodaterolTiotropium BromideCCQClinical COPD QuestionnaireCOPDnon-interventional studyolodateroltiotropium

Identifiers

PMID33731991
PMCPMC7956863
OpenAlexW3135552733

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.