Skip to main content
OpenTrials
Completed

NCT Number: NCT02552160

DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy

Prospective, multi-centre, non-interventional study to collect findings about the effects of LABA/LAMA (Long Acting Beta2-Agonists / Long Acting Muscarinic Antagonists) combination preparations on COPD (Chronic obstructive pulmonary disease) symptoms and quality of life under real conditions and to find out what types of patients are selected for this therapy by physicians.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aachen, D6570r00001, Germany

Loading trial locations.

About this study

Retrospective aspect of documentation: For patients who have already been changed over to a fixed-dose combination, lung function parameters and CAT (COPD Assessment Test™) score from the time prior to the changeover will be documented.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female/male of at least 40 years of age
  • Patient diagnosed with COPD
  • Patient was changed over within the last 3 months to a fixed-dose combination (FDC) (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol), or there is already the intent to change the patient over to a fixed-dose combination (Aclidinium/Formeterol, Glycopyrronium/Indacaterol or Umeclidinium/Vilanterol).
  • Lung function parameters and CAT score from the time prior to the changeover to an FDC are on record (within the last 6 months in the case of patients who have already been changed over) or are determined at the 1st visit (in the case of patients who have not yet been changed over but for whom such a changeover is intended).
  • Signed declaration of consent

Exclusion criteria

  • The prescribing information for the fixed-dose combinations (Duaklir® Genuair®, Ulibtro® Breezhaler® or Anoro®) list contraindications for the patient.
  • Patient is pregnant, plans to become pregnant, or is nursing during the therapy period.
  • Patient suffers from hypersensitivity to one of the active ingredients of the fixed-dose combinations.
  • Patient is participating in a clinical trial.

Treatment and study plan

Primary outcomes

  1. Lung function

    Time frame: First visit (baseline)

    Assessment of FEV1 (Forced Expiratory Volume), FVC (Forced Vital Capacity)

  2. Number of patients with concomitant diseases classified by diagnostic subgroups

    Time frame: First visit (baseline)

  3. Number of patients receiving concomitant COPD (Chronic obstructive pulmonary disease) medication classified by therapeutic subgroups

    Time frame: First visit (baseline)

  4. Number of patients with exacerbations within the previous 24 months

    Time frame: First visit (baseline)

    History of previous exacerbations that will be collected at first observational visit.

Secondary outcomes

  1. Change in well-being and quality of life

    Time frame: First visit (baseline) to end of observational period at 12 months

    CAT (COPD Assessment Test™) questionnaire will be completed at each visit, approximately every 3 months.

  2. Effect on the severity of the shortness of breath

    Time frame: First visit (baseline) to end of observational period at 12 months

    mMRC (modified Medical Research Council Dyspnea Scale) questionnaire will be completed at each visit, approximately every 3 months.

  3. Change in the night-time and early-morning COPD symptoms

    Time frame: First visit (baseline) to end of observational period at 12 months

    NiSCI/EMSCI (Night-time symptoms of COPD Instrument / Early-morning symptoms of COPD instrument) questionnaire will be completed at each visit, approximately every 3 months.

  4. Lung function

    Time frame: First visit (baseline) to end of observational period at 12 months

    Assessment of FEV1, FVC at each visit, approximately every 3 months.

  5. Number of exacerbations by grade

    Time frame: First visit (baseline) to end of observational period at 12 months

    Number of exacerbations will be collected at each visit, approximately every 3 months

  6. Adverse events

    Time frame: First visit (baseline) to end of observational period at 12 months

    Adverse events will be collected at each visit, approximately every 3 months.

  7. Handling of inhaler

    Time frame: At 12 months

    Questionnaire regarding handling of inhaler by patient

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Non-interventional Study for Documentation of the Therapeutic Efficacy, Use and Tolerance of the Fixed-Dose Combinations (FDC) Duaklir® Genuair® (Aclidinium/Formoterol), Ultibro® Breezhaler® (Glycopyrronium/Indacaterol) and Anoro® (Umeclidinium/Vilanterol) in the Treatment of COPD Under Real Conditions in the Practices of Pneumologists, Internists, and General Practitioners

Acronym: DETECT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2015
Registry last updated
Dec 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.