NCT07856667

Brief Summary

Patients with chronic obstructive pulmonary disease (COPD) and severe asthma frequently present with cardiovascular comorbidities that contribute substantially to morbidity and mortality. Early identification and appropriate management of cardiovascular disease are increasingly recognized as important components of comprehensive care for patients with obstructive airway diseases. The COINCIDE study is a prospective longitudinal observational cohort study conducted at the Department of Pulmonology, Medical University of Innsbruck. The study aims to systematically document cardiovascular comorbidities in patients with COPD and severe asthma and to evaluate their association with disease progression, therapeutic management, exacerbation rates, symptom burden, and pulmonary function over time. Clinical, functional, laboratory, and imaging data obtained as part of routine clinical care will be collected prospectively during two study visits separated by approximately 24 months. Up to 350 adult participants will be enrolled and followed over a period of five years.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Oct 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 2, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

October 15, 2026

Expected
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2031

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2031

Last Updated

October 2, 2026

Status Verified

September 1, 2026

Enrollment Period

4.6 years

First QC Date

September 28, 2026

Last Update Submit

September 28, 2026

Conditions

Keywords

COPDChronic Obstructive Pulmonary DiseaseSevere AsthmaCardiovascular ComorbidityCardiovascular DiseasePulmonologyCohort StudyLongitudinal StudyReal World Data

Outcome Measures

Primary Outcomes (1)

  • Prevalence and characterization of cardiovascular comorbidities

    Assessment of the prevalence, type, and distribution of cardiovascular comorbidities in patients with COPD and severe asthma based on clinical, laboratory, and imaging findings obtained during routine care.

    Baseline and 24 months

Secondary Outcomes (4)

  • Exacerbation Frequency

    24 months

  • Symptom Burden

    24 months

  • Pulmonary Function

    Baseline and 24 months

  • Treatment Modifications

    24 months

Interventions

Participants receive routine medical care according to local standards of care. No study-specific intervention, treatment allocation, or diagnostic procedure is performed.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients (≥18 years) with a diagnosis of COPD GOLD Group B or E or severe asthma according to current GOLD and GINA recommendations. Participants are recruited from the specialized pulmonary outpatient clinic of the Department of Internal Medicine II, Medical University of Innsbruck, and receive routine clinical care. Patients are followed prospectively to assess cardiovascular comorbidities and their impact on clinical outcomes.

You may qualify if:

  • Male or female participants aged 18 years or older.
  • Diagnosis of COPD GOLD Group B or E according to current GOLD recommendations, or severe asthma according to current GINA recommendations.
  • Receiving care at the specialized pulmonary outpatient clinic of the Department of Internal Medicine II, Medical University of Innsbruck.
  • Ability to provide written informed consent.

You may not qualify if:

  • Age below 18 years.
  • Inability or unwillingness to participate in study procedures.
  • Inability or unwillingness to provide written informed consent.
  • Planned transfer of care preventing longitudinal follow-up.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveAsthmaCardiovascular Diseases

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchial DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Thomas Sonnweber

    Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2026

First Posted

October 2, 2026

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

May 15, 2031

Study Completion (Estimated)

June 15, 2031

Last Updated

October 2, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share