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

NCT06170125 | Not Yet Recruiting

• 1 other identifier: 2023-TIO-EL-187
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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 function) and validated patient-reported outcomes (PROs) are used in clinical trials to assess disease severity and response to treatment. The PROs are different in terms of their scope of assessment and in the information that they capture. PRO questionnaires such as the Baseline Dyspnoea Index (BDI), Transition Dyspnoea Index (TDI) and modified Medical Research Council (mMRC) dyspnoea scale are used to assess dyspnoea, whereas the Clinical COPD Questionnaire (CCQ), COPD Assessment Test (CAT) and St George's Respiratory Questionnaire (SGRQ) are commonly used to assess patients' health status . Furthermore, the mMRC scale is unidirectional and minimally responsive to treatment interventions, while the BDI, TDI, CAT, CCQ and SGRQ (approved by the USA Food and Drug Administration) are multidirectional.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Quality of Life assesment

  Change in Clinical COPD Questionnaire (CCQ)

  6 months

Secondary Outcomes (6)

• Dyspnea assesment

  6 months

• COPD Assessment Test

  6 months

• FEV1 % predicted measurement

  6 months

• Feeling of Satisfaction with Inhaler (FSI-10) questionnaire

  6 months

• Exacerbations

  6 months

Interventions

Tiotropium treated patients OTHER

Patients who are not satisfied with their COPD treatment and will be on additional tiotropium scheme.

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients patients (≥40 years old) with a diagnosis of Chronic Respiratory Pulmonary Disease (COPD) who were treated with 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Related Publications (3)

• Kostikas K, Greulich T, Mackay AJ, Lossi NS, Aalamian-Mattheis M, Nunez X, Pagano VA, Patalano F, Clemens A, Vogelmeier CF. Treatment response in COPD: does FEV1 say it all? A post hoc analysis of the CRYSTAL study. ERJ Open Res. 2019 Feb 25;5(1):00243-2018. doi: 10.1183/23120541.00243-2018. eCollection 2019 Feb.

  PMID: 30815470 BACKGROUND

• Kostikas K, Mackay AJ, Vogelmeier CF, Frent SM, Gupta P, Banerji D, Patalano F, Pfister PJ, Wedzicha JA. Early Clinically Important Improvement (ECII) and Exacerbation Outcomes in COPD Patients. Int J Chron Obstruct Pulmon Dis. 2020 Jul 28;15:1831-1838. doi: 10.2147/COPD.S247966. eCollection 2020.

  PMID: 32884253 BACKGROUND

• Anzueto A, Miravitlles M. Tiotropium in chronic obstructive pulmonary disease - a review of clinical development. Respir Res. 2020 Jul 29;21(1):199. doi: 10.1186/s12931-020-01407-y.

  PMID: 32727455 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: February 1, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share