Status:

COMPLETED

Effects of a Food Supplement on Quality of Life in Patients With Chronic Obstructive Pulmonary Disease.

Lead Sponsor:

Arafarma Group, S.A.

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

It has been demonstrated that consequences of malnutrition affect a situation of risk and have negative effects on the evolution of chronic obstructive pulmonary disease (COPD), accompanied by higher ...

Detailed Description

This study is developed in two phases: pilot phase and experimental phase. The pilot phase is preliminary and progressive in order to demonstrate a sufficient effect of improving the quality of life o...

Eligibility Criteria

Inclusion

  • Adults: men and women ≥ 18 years.
  • Patients with a medical diagnosis of COPD based on a recent spirometry.
  • Patients with a CAT score\> 15, affecting COPD symptoms in a moderate-high way in the daily life of these patients.
  • Minimum clinical stability period of 4 weeks before the start of the study.
  • Patients who are trained to give informed consent.
  • Patients must agree to perform study visits and procedures with precise instructions.

Exclusion

  • BMI ≥ 40.
  • Comorbidities, which due to their severity or progression, may interfere with the results, such as cancer, hematological disorders, severe heart or liver failure, kidney failure on dialysis, tuberculosis (TB) or AIDS, or other pulmonary pathologies such as pulmonary thromboembolism ( PE), pulmonary fibrosis, or relevant bronchiectasis.
  • In Pulmonary Rehabilitation treatment or in treatment for smoking.
  • Pregnancy or breastfeeding.
  • Impossibility of the patient, due to a medical condition, to follow the study.

Key Trial Info

Start Date :

January 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 3 2022

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT04815499

Start Date

January 14 2020

End Date

November 3 2022

Last Update

November 15 2022

Active Locations (1)

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Hospital Universitario Doctor Peset

Valencia, Spain, 46017