Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04815499
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 25, 2021
Sponsor:
Information provided by (Responsible Party):
Arafarma Group, S.A.

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 morbidity and mortality. The impact of malnutrition on the respiratory system affects the respiratory muscles, the lung parenchyma, and the immune system. In summary, the risk of complications can lead to a worsening of the quality of life of the COPD patient. Also, dyspnea as the main symptom of COPD is the one that produces the greatest loss of quality of life, especially in older patients. The components of our authorized food supplement improve the quality of life of the patient. These components maintain the strength and energy of the patient, help the body to recover and regain its optimal state, help improve the immune system, help reduce the side effects of therapies associated with the control or cure of cancer and help correct nutritional deficiencies. This is the reason why this experimental study aims to improve the quality of life in patients with COPD with a CAT score>15.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Dietary Supplement: Food supplement Dietary Supplement: Placebo Not Applicable

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 of patients and to be able to continue in an experimental phase with more investigational sites and more patients, and to evaluate other secondary objectives.

Once the pilot phase is finished, an intermediate analysis of the results will be carried out to evaluate the magnitude of the variation in quality of life at 3, 6, 9 and 12 months. If the expected success expectations are achieved and it is approved by the Ethics Committee, the study will continue to the experimental phase.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Study of the Impact on Quality of Life With ARACOMPLEX® Food Supplement Versus Placebo in Chronic Obstructive Pulmonary Disease Patients With a CAT Score> 15.
Actual Study Start Date : January 14, 2020
Estimated Primary Completion Date : January 14, 2022
Estimated Study Completion Date : April 14, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Food supplement
One tablet a day, during 12 months
Dietary Supplement: Food supplement
ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.

Placebo Comparator: Placebo
One tablet a day, during 12 months
Dietary Supplement: Placebo
Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.




Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: 12 months ]
    To assess the magnitude of the change from baseline quality of life at 3 months, 6 months, 9 months and 12 months using the COPD Assessment Test (CAT) scale in COPD patients with a CAT score> 15 who receive ARACOMPLEX® supplementation compared to those patients receiving placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815499


Contacts
Layout table for location contacts
Contact: Elena Justicia +34 661 647 315 pm.1@clinicalpi.com
Contact: Carles Iglesias scientificdirector@clinicalpi.com

Locations
Layout table for location information
Spain
Hospital Universitario Doctor Peset Recruiting
Valencia, Spain, 46017
Contact: Alberto Herrejón, Doctor    +34961622488    herrejon_alb@gva.es   
Principal Investigator: Alberto Herrejón, Dr.         
Sponsors and Collaborators
Arafarma Group, S.A.
Layout table for additonal information
Responsible Party: Arafarma Group, S.A.
ClinicalTrials.gov Identifier: NCT04815499    
Other Study ID Numbers: ARA-EXP/ARA-2019-01
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 25, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases