Chronic Obstructive Pulmonary DiseaseEPOCATNCT04815499
Effects of a Food Supplement on Quality of Life in Patients With Chronic Obstructive Pulmonary Disease.
A study testing Food supplement in people with Chronic Obstructive Pulmonary Disease, run by Arafarma Group, S.A. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Food supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jan 2020to 3 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Food supplement, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food supplementDietary 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.
PlaceboDietary supplement
Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.
| Study group | Role | What they receive |
|---|---|---|
| Food supplement | Experimental | One tablet a day, during 12 months Receives: Dietary Supplement: Food supplement |
| Placebo | Placebo comparator | One tablet a day, during 12 months Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2021
- Study start14 Jan 2020
- Primary completion15 Sep 2022
- Study completion3 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arafarma Group, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04815499
- Sponsor's protocol ID
- ARA-EXP/ARA-2019-01
- Acronym
- EPOCAT
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04815499
- Acronym / sponsor ID
- EPOCAT / ARA-EXP/ARA-2019-01
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Arafarma Group, S.A.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 3 Nov 2022 (actual)
- First posted
- 25 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food supplement | Experimental | Dietary Supplement: Food supplementOne tablet a day, during 12 months |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne tablet a day, during 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food supplementARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient. | Dietary supplement | Food supplement |
| PlaceboPlacebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®. | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food supplement in people with Chronic Obstructive Pulmonary Disease, run by Arafarma Group, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.