Status:

NOT_YET_RECRUITING

QualiTy of Life Evaluation in Patients With ChRonic ObstructIve Pulmonary Disease Who Require Tiotropium as additiOnal treatmeNt.

Lead Sponsor:

Elpen Pharmaceutical Co. Inc.

Conditions:

COPD

Eligibility:

All Genders

40-90 years

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a complex, heterogeneous disease usually with a decline lung function and worsening symptoms; hence, both forced expiratory volume in 1 s (FEV1; lung fu...

Detailed Description

With the availability of numerous PROs, it is important to understand which provide a better evaluation of patients' health status and demonstrate responses to treatment. Even when PROs evaluate the s...

Eligibility Criteria

Inclusion

  • Adult patients (≥40 years old) with a diagnosis of Chronic Respiratory Pulmonary Disease (COPD).
  • Patients who were treated with Inhaled Corticosteroid (ICS)/LABA, LABA/LAMA with a LABA or ICS/LABA or were not receiving long-acting bronchodilators (LABA or LAMA) for COPD and required addition of tiotropium from 1 to 7 days before the start of the study.
  • Patients who are able to provide informed consent and follow study procedures and requirements.

Exclusion

  • According to the contraindications of the product's Summary of Product Characteristics.
  • Patients receiving LAMA monotherapy prior to study entry.

Key Trial Info

Start Date :

March 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

February 1 2026

Estimated Enrollment :

500 Patients enrolled

Trial Details

Trial ID

NCT06170125

Start Date

March 1 2024

End Date

February 1 2026

Last Update

February 20 2024

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