Multidimensional Approach for COPD and High Complexity (MACH)

February 21, 2023 updated by: Prof Domenico Di Raimondo, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Clinical and Prognostic Evaluation of COPD Patients: Managing Multimorbidity Using a Multidimensional Approach

The MACH Study trial will examine the impact on high complexity COPD patients of a multidimensional approach (moderate-intensity physical activity program and clinic-therapeutic re-evaluation of the participants)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

MACH Study investigators designed a trial to evaluate in high complexity subjects (at least 2 chronic diseases):

in the COPD cohort, the impact of a multidimensional approach involving global therapeutic remodeling (re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions) plus a 24-weeks moderate intensity physical activity program on: number of total and severe exacerbations; number of total and COPD/related hospitalizations; quality of life; survival over a 36 months follow-up period;
to establish whether a higher index of comorbidity and polypharmacy is independently associated with a worst clinical severity of COPD, an increased risk of exacerbations and a reduced survival;
the role played by specific clinical-laboratory markers of comorbidity (blood iron profile, hemochromocytometric parameters, renal function, blood pressure profile, glycemic compensation, Body Mass Index, lipid profile) and specific multidimensional tests in identifying COPD patients with higher clinical risk of rapid disease decline and/or higher risk of exacerbations and COPD-related hospitalizations;
to establish the role of Heart Failure as the most impactful comorbidity of COPD: assess the incidence rate and the relative risk of total/severe exacerbation and the incidence rate and the relative risk of total/COPD-related hospitalizations in Heart Failure/COPD patients over a 36-months follow-up period;
at the enrollment time (zero time) and after 12, 24 and 36 months, circulating levels of several systemic inflammation biomarkers. Correlate their variation over time with the comorbidity indexes, global pharmacological therapeutic redefinition and lifestyle intervention centered on 24-weeks physical activity program;
at the enrollment time (zero time) and after 12, 24 and 36 months, plasma levels of the main miRNAs involved in the COPD pathogenesis. Correlate their variation over time with the comorbidity indexes, global pharmacological therapeutic redefinition and lifestyle intervention centered on 24-weeks physical activity program;
at the enrollment time (zero time) and after 12, 24 and 36 months, plasma levels of the main myokines currently associated with the systemic effects of physical activity, correlating their baseline concentration to clinical-anthropometric parameters and type and number of chronic diseases and their variation over time in relation to the global pharmacological therapeutic redefinition and the 24-weeks physical activity program;

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Domenico Di Raimondo
Phone Number: +390916552180
Email: domenico.diraimondo@unipa.it

Study Locations

Italy
- - Palermo, Italy, 90127
    - Recruiting
    - Domenico Di Raimondo
    - Contact:
      
      Domenico Di Raimondo
      
      Phone Number: +390916552180
      
      Email: domenico.diraimondo@unipa.it
    - Principal Investigator:
      
      Domenico Di Raimondo, MD PhD
    - Sub-Investigator:
      
      Edoardo Pirera, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Provide signed and dated informed consent form;
Willing to comply with all study procedures and be available for the duration of the study;
COPD diagnosis (according to "Global Initiative for Chronic Obstructive Lung Disease" (GOLD) 2020 Guidelines) or HF diagnosis (according to European Society of Cardiology (ESC) 2016 Guidelines for the diagnosis and treatment of acute and chronic heart failure);
Diagnosis at least two other chronic diseases, in addition to COPD (Group A) or HF (Group B). If COPD and HF diagnoses are both present in the same subject, COPD or HF will be considered as the index pathology in view of the clinical relevance and ergo, the participant will be included in the group A or in the group B;
Healthy subjects exclusively for Group C;

Chronic diseases are considered the following:

Type 1 or Type 2 Diabetes mellitus
Essential hypertension
Chronic Kidney Disease Stage 3b or worst (Glomerular Filtration Rate < 44 mL/min/1.73 m^2 estimated through the Cockcroft-Gault formule)
Chronic Anemia of moderate level of lower (Haemoglobin levels ≤10.9 g/dl) according to World Health Organization (WHO) classification
Chronic liver disease (every etiology)
Obesity (Body Mass Index ≥ 30)

Exclusion Criteria:

Active cigarette smoking;
Need for continuous supportive oxygen therapy, regardless of the flow required;
Distance covered during the 6 minutes walking test (6MWT) < 300 meters;
Unstable angina pectoris or angina pectoris at rest, a history of cardiac arrest, "New York Heart Association" (NYHA) Class III or IV congestive heart failure or severe left ventricular systolic dysfunction (EF <30%), acute myocarditis, pericarditis or hypertrophic myocardiopathy, clinically significant aortic stenosis, cardiac defibrillator, heart transplant, history of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair;
Uncontrolled or partially controlled asthma despite optimal treatment; Sleep apnea syndrome; history of pulmonary fibrosis;
Recent acute cardiac or cerebral event in the last six months;
Child-Pugh B/C cirrhosis;
Body Mass Index ≥ 35;
Evidence of any arrhythmia (uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more), left bundle branch block or cardiac pacemaker, etc.) that contraindicates or makes unsafe the fulfilment of the regular physical activity program, assessed on the basis of the clinical history, documentation presented and clinical and instrumental evaluation carried out at the time of enrollment;
Resting heart rate less than 45 beats per minute or greater than 100 beats per minute;
History of uncontrolled or partially controlled high blood pressure despite optimal treatment;
Regular physical activity practice (the level of habitual physical activity practiced will be ascertained by administering specific questionnaires. Only sedentary participants will be eligible);
Inability to perform the 24-weeks physical activity program for any cause (muscle, joint, respiratory, neurological, vascular, diabetes complications);
Any acute or chronic disease, already known at the time of enrollment, capable of altering systemic inflammation biomarkers and cytokine profile (e.g. sepsis, infections, immune-rheumatological diseases, hematological diseases, etc.).
Any muscle condition, inflammatory or not, capable of altering muscular myokines' release (polymyositis, rheumatic polymyalgia, fibromyalgia);
Acute bleeding at the time of enrollment or any anemia that would have been required urgent transfusion within the past three months;
Solid or hematological neoplasia under active (at the time of enrollment) or recent (ended less than 6 months earlier) chemo-radiotherapy treatment at the time of enrollment;
Current diagnosis of schizophrenia, other psychotic disorders or bipolar disorder uncontrolled or partially controlled despite optimal treatment;
Self-report of alcohol or substance abuse within the past twelve months, current consumption of more than 14 alcoholic drinks per week, and/or current acute treatment or rehabilitation program for these problems;
Severe cognitive impairment or anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study;
Conditions not specifically mentioned above that may serve as criteria for exclusion at the discretion of the PI and study staff;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GROUP "COPD" 100 participants, 50 males and 50 females with COPD and multiple chronic conditions	Behavioral: Physical activity program 24-weeks moderate-intensity physical activity program Other: Global therapeutic remodeling Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions
Active Comparator: GROUP "HF" 100 participants, 50 males and 50 females with HF and multiple chronic conditions	Behavioral: Physical activity program 24-weeks moderate-intensity physical activity program Other: Global therapeutic remodeling Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions
Active Comparator: GROUP "HEALTHY PARTICIPANTS" 100 healthy participants or "control group" which will be compared to Group A and Group B by age and sex	Behavioral: Physical activity program 24-weeks moderate-intensity physical activity program Other: Global therapeutic remodeling Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of COPD exacerbation of Group "COPD" Time Frame: Baseline to 12 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year. The severity of COPD exacerbation will be assessed as follow: Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;	Baseline to 12 months
Cumulative incidence of COPD exacerbation of Group "COPD" Time Frame: Baseline to 24 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year. The severity of COPD exacerbation will be assessed as follow: Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;	Baseline to 24 months
Cumulative incidence of COPD exacerbation of Group "COPD" Time Frame: Baseline to 36 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of COPD exacerbation per year. The severity of COPD exacerbation will be assessed as follow: Mild: treated with short acting bronchodilators only; Moderate: treated with bronchodilators and/or oral corticosteroids; Severe: patient requires hospitalization or visits the emergency room;	Baseline to 36 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD" Time Frame: Baseline to 12 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for pneumonia. Pneumonia will be ascertain clinically and/or radiologically.	Baseline to 12 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD" Time Frame: Baseline to 24 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for pneumonia. Pneumonia will be ascertain clinically and/or radiologically.	Baseline to 24 months
Cumulative incidence of hospitalization for pneumonia of Group "COPD" Time Frame: Baseline to 36 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization per year for severe COPD exacerbation and pneumonia. Pneumonia will be ascertain clinically and/or radiologically.	Baseline to 36 months
Cumulative incidence of hospitalizations for any cause of Group A Time Frame: Baseline to 12 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.	Baseline to 12 months
Cumulative incidence of hospitalizations for any cause of Group A Time Frame: Baseline to 24 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.	Baseline to 24 months
Cumulative incidence of hospitalizations for any cause of Group A Time Frame: Baseline to 36 months	The effect of a 24-weeks moderate-intensity physical activity program and re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions on the number of hospitalization for any cause per year.	Baseline to 36 months
Mortality rate of Group "COPD" Time Frame: Baseline to 12 months	The number of total deaths in the time frame of 12 months in Group "COPD"	Baseline to 12 months
Mortality rate of Group "COPD" Time Frame: Baseline to 24 months	The number of total deaths in the time frame of 24 months in Group "COPD"	Baseline to 24 months
Mortality rate of Group "COPD" Time Frame: Baseline to 36 months	The number of total deaths in the time frame of 36 months in Group "COPD"	Baseline to 36 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.	Baseline to post-interventions at 12 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD" Time Frame: Baseline to 24 months	Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.	Baseline to 24 months
Change over time from baseline in Mini Nutritional Assessment-Short Form total score of Group "COPD" Time Frame: Baseline to 36 months	Mini Nutritional Assessment is a simple tool that helps physicians to have knowledge of nutritional status in elderly persons. It was well validated in the hospital, community and long-term care settings.	Baseline to 36 months
Change over time from baseline in EQ-5D-3L of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)	Baseline to post-interventions at 12 months
Change over time from baseline in EQ-5D-3L of Group "COPD" Time Frame: Baseline to 24 months	The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)	Baseline to 24 months
Change over time from baseline in EQ-5D-3L of Group "COPD" Time Frame: Baseline to 36 months	The EQ-5D-3L is a generic, multidimensional, health-related, quality-of-life instrument using a three-level scale 1-3 (no problem, some problems and extreme problems)	Baseline to 36 months
Change over time from baseline in mMRC of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects. Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"	Baseline to post-interventions at 12 months
Change over time from baseline in mMRC of Group "COPD" Time Frame: Baseline to 24 months	mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects. Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"	Baseline to 24 months
Change over time from baseline in mMRC of Group "COPD" Time Frame: Baseline to 36 months	mMRC is a simple tool that investigates the measure of breathlessness of COPD subjects. Grade 0: "I only get breathless with strenuous exercise " Grade 1: I get short of breath when hurrying on the level or walking up a slight hill" Grade 2: "I walk slower than people of same age on the level because of breathlessness or I have to stop to catch breath when walking at their own pace on the level" Grade 3: "I stop for breath after walking ∼100 m or after few minutes on the level" Grade 4: "I am too breathless to leave the house, or breathless when dressing or undressing"	Baseline to 36 months
Change over time from baseline in CAT of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.	Baseline to post-interventions at 12 months
Change over time from baseline in CAT of Group "COPD" Time Frame: Baseline to 24 months	The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.	Baseline to 24 months
Change over time from baseline in CAT of Group "COPD" Time Frame: Baseline to 36 months	The COPD Assessment Test (CAT) is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time. The CAT is simple to administer, and aims to help clinicians, with their patients, better manage COPD.	Baseline to 36 months
Change over time from baseline in Barthel Index of Group "COPD" Time Frame: Baseline to post interventions at 12 months	The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.	Baseline to post interventions at 12 months
Change over time from baseline in Barthel Index of Group "COPD" Time Frame: Baseline to 24 months	The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.	Baseline to 24 months
Change over time from baseline in Barthel Index of Group "COPD" Time Frame: Baseline to 36 months	The Maryland Disability Index (formally Barthel Index) was codified in the late 1950s by the english nurse Barthel. It allows to have knowledge of the degree of subject's independence. It consists of 10 items that explore common "Activities of Daily Living (ADL)", from nutrition to the ability to climb or descend stairs. Each item is assigned an arbitrary score of 5, 10 or 15 points (maximum 100). The sum indicates the degree of autonomy of the patient in carrying out daily activities.	Baseline to 36 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD" Time Frame: Baseline to post interventions at 12 months	The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel	Baseline to post interventions at 12 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD" Time Frame: Baseline to 24 months	The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel	Baseline to 24 months
Change over time from baseline in 6-minutes Walking Test (6-mWT) of Group "COPD" Time Frame: Baseline to 36 months	The 6-mWT measures the distance a subject walks while walking fast. The protocol used is standardized (a protocol with written instructions identical for all is used) and performed by specially trained personnel	Baseline to 36 months
Change over time from baseline in BODE Index of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.	Baseline to post-interventions at 12 months
Change over time from baseline in BODE Index of Group "COPD" Time Frame: Baseline to 24 months	The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.	Baseline to 24 months
Change over time from baseline in BODE Index of Group "COPD" Time Frame: Baseline to 36 months	The BODE index, for Body-mass index, airflow Obstruction, Dyspnea, and Exercise, is a multidimensional scoring system and capacity index originally designed to predict mortality in patients with COPD.	Baseline to 36 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.	Baseline to post-interventions at 12 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD" Time Frame: Baseline to 24 months	24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.	Baseline to 24 months
Change over time from baseline in 24-hour average systolic and diastolic pressures of Group "COPD" Time Frame: Baseline to 36 months	24-hour average systolic and diastolic pressures will be assessed performing a 24-hour Ambulatory Blood Pressure Monitoring.	Baseline to 36 months
Change over time from baseline in heart rate variability of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	Heart rate variability will be assessed performing a 24-ECG Holter	Baseline to post-interventions at 12 months
Change over time from baseline in heart rate variability of Group "COPD" Time Frame: Baseline to 24 months	Heart rate variability will be assessed performing a 24-ECG Holter	Baseline to 24 months
Change over time from baseline in heart rate variability of Group "COPD" Time Frame: Baseline to 36 months	Heart rate variability will be assessed performing a 24-ECG Holter	Baseline to 36 months
Change over time from baseline in fasting blood sugar of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	Fasting blood sugar will be performed using the the dextrostix	Baseline to post-interventions at 12 months
Change over time from baseline in fasting blood sugar of Group "COPD" Time Frame: Baseline to 24 months	Fasting blood sugar will be performed using the the dextrostix	Baseline to 24 months
Change over time from baseline in fasting blood sugar of Group "COPD" Time Frame: Baseline to 36 months	Fasting blood sugar will be performed using the the dextrostix	Baseline to 36 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD" Time Frame: Baseline to post-interventions at 12 months	Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test	Baseline to post-interventions at 12 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD" Time Frame: Baseline to 24 months	Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test	Baseline to 24 months
Variation over time (percentage/year) of Forced Expiratory Volume in the 1st second (FEV1) of Group "COPD" Time Frame: Baseline to 36 months	Forced Expiratory Volume in the 1st second (FEV1) will be assessed performing the spirometric test	Baseline to 36 months

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Investigators

Principal Investigator: Domenico Di Raimondo, University of Palermo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2026

Study Registration Dates

First Submitted

July 9, 2021

First Submitted That Met QC Criteria

July 30, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MACH Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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