ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Triple Therapy in COPD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03724877
Recruitment Status : Completed
First Posted : October 30, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To assess the effectiveness of maintenance treatment of Chronic obstructive pulmonary disease (COPD) with the Long-acting beta2-agonist - long-acting muscarinic antagonists-inhaled corticosteroids (LABA-LAMA-ICS) combination with a LABA-LAMA combination on the risk of COPD exacerbation and the safety on the incidence of community acquired pneumonia.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS) Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)

Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparative Effectiveness of Triple Therapy in COPD: A New-user Cohort Study
Actual Study Start Date : November 10, 2018
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
Subjects with Chronic obstructive pulmonary disease (COPD) Drug: Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)
(LABA-LAMA-ICS)

Drug: Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)
(LABA-LAMA)




Primary Outcome Measures :
  1. Number of subjects hospitalised with severe exacerbation [ Time Frame: 1 year ]
    primary diagnosis-hospitalisation

  2. Number of subjects hospitalised with moderate exacerbation [ Time Frame: 1 year ]
    on prescription of oral corticosteriod

  3. Number of subjects hospitalised with community-acquired pneumonia (serious pneumonia) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. rate of Chronic obstructive pulmonary disease (COPD) exacerbation [ Time Frame: 1 year ]
    based on the number of hospitalizations and on the number of courses of treatment with an oral corticosteroid



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Incident new-user cohort design with high-dimensional propensity scores to match the two comparison groups of COPD.
Criteria

Inclusion Criteria:

  • New users of long-acting bronchodilators, Long-acting beta2-agonist (LABA) and long-acting muscarinic antagonists (LAMA) on the same date or of LABA, LAMA and inhaled corticosteroids (ICS), either as a fixed-dose combination (LABA-ICS) or free combination, on the same date between January 2002 and December 2016.
  • Diagnosis of Chronic obstructive pulmonary disease (COPD) prior to first maintenance inhaler and age ≥ 55 years at forst maintenance inhaler.

Exclusion Criteria:

  • Less than one year of medical history information prior to the date of combined treatment initiation (study cohort entry)
  • Asthma diagnosis prior to study cohort entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724877


Locations
United Kingdom
Clinical Practice Research Datalink
London, United Kingdom, E14 4PU
Sponsors and Collaborators
Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03724877     History of Changes
Other Study ID Numbers: 1237-0078
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Cholinergic Agents
Muscarinic Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists