COPD ExacerbationPRIMENCT03701945
Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
A study testing Pulmonary rehabilitation in people with COPD Exacerbation and COPD, run by Aveiro University at 1 site in Portugal.
Trial summary
PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD Exacerbation, COPD
- What is being tested?
- Pulmonary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2018to 30 Jun 2021
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible if adults (≥18anos) and present a diagnose of chronic obstructive pulmonary disease (COPD).
Who cannot join
- Patients will be excluded if they had an acute cardiovascular event on the previous month or if they have a significant cardiac, immune, musculoskeletal or neurological impairment, or any other that doesn't allow them to perform tests.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
University of Aveiro
Aveiro, 3810-193
Alda S. Marques, PhD, 00351 234 372 462, amarques@ua.pt
Alda S. Marques, PhD
About this study
PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.
Read the detailed description
PRIME aims to address these two gaps, establishing the role of microbiota and clinical data in predicting AECOPD and increasing the evidence on PR in AECOPD through the translation of PR guidelines to the community. Specifically, it aims to:
- Explore the longitudinal changes in microbiota and clinical data between stable and exacerbations periods;
- Establish the feasibility and short- and long-term effects of community-based PR for AECOPD;
- Define the characteristics of patients who most benefit from community-based PR. 156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR. A clinical decision-making tool (CDMT) to prioritise patients with AECOPD for PR will be developed.
The experienced multidisciplinary team will ensure the following novel results:
- a clinical and lung microbiota profile of patients with COPD;
- a model of AECOPD prediction;
- recommendations for community-based PR in AECOPD;
- a CDMT to prioritise patients with AECOPD for PR.
PRIME will contribute to optimise outcomes, improve AECOPD healthcare services and reduce the burden with COPD.
- Conditions
- COPD Exacerbation, COPD
- Being tested
- Pulmonary rehabilitation
- Keywords
- microbiota, pulmonary rehabilitation
- 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.
Pulmonary rehabilitationOther
Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Pulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation Receives: Other: Pulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in exercise tolerance
exercise tolerance in a walking field test
Measured: Up to 6 months
Change in lung microbiota
lung microbiota from saliva samples
Measured: Up to 6 months
Secondary outcomes (11)
Change in muscle strength
Upper and lower limb muscle strength
Measured: Up to 6 months
Change in health related Quality of life
Measured with the St. George's Respiratory Questionnaire, that measures health related quality of life. It will be used the total score. Scores are expressed as a percentage of overall impairment where 100 represents worst possible health status and 0 indicates best possible health status.
Measured: Up to 6 months
Change in resting dyspnoea
Resting dyspnoea measured with the modified British medical research council dyspnoea questionnaire, that ranges from 0 to 4, and is related to dyspnoea during activities of daily living. Higher scores demonstrate a higher functional impairment due to dyspnoea.
Measured: Up to 6 months
Change in self-efficacy
self-efficacy measured with the pulmonary rehabilitation adapted index of self-efficacy tool
Measured: Up to 6 months
Change in physical activity
Physical activity levels measured with the brief physical activity assessment tool
Measured: Up to 6 months
Change in lung function
Lung function will be assessed through spirometry to define the airflow limitation (FEV1pp).
Measured: Up to 6 months
Change in emergency department visits
Number of emergency visits on the previous year
Measured: Up to 6 months
Change in frequency of exacerbations
Number of exacerbations on previous year
Measured: Up to 6 months
Change in hospitalizations
Number of hospitalizations on previous year
Measured: Up to 6 months
Dyspnoea during exercise
Dyspnoea experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no dyspnoea and 10 the worst imaginable dyspnoea.
Measured: Up to 6 months
Fatigue during exercise
Fatigue experienced during exercise, monitored with the modified Borg dyspnoea scale, that ranges from 0 to 10, where 0 represents no fatigue and 10 the worst fatigue the patient can imagine.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Oct 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Treatment
- Intervention model
- Sequential
- Model description
- 156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR.
- Masking
- None (open label)
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda Marques, PhD, Principal investigator, School of Health Sciences, University of Aveiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701945
- Sponsor's protocol ID
- POCI-01-0145-FEDER-028806
- Acronym
- PRIME
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
PubMed 35514131
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD
- ClinicalTrials.gov ID
- NCT03701945
- Acronym / sponsor ID
- PRIME / POCI-01-0145-FEDER-028806
- Conditions
- COPD Exacerbation, COPD
- Keywords
- microbiota, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 10 Oct 2018 (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.
PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.
Detailed description
PRIME aims to address these two gaps, establishing the role of microbiota and clinical data in predicting AECOPD and increasing the evidence on PR in AECOPD through the translation of PR guidelines to the community. Specifically, it aims to:
- Explore the longitudinal changes in microbiota and clinical data between stable and exacerbations periods;
- Establish the feasibility and short- and long-term effects of community-based PR for AECOPD;
- Define the characteristics of patients who most benefit from community-based PR. 156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR. A clinical decision-making tool (CDMT) to prioritise patients with AECOPD for PR will be developed.
The experienced multidisciplinary team will ensure the following novel results:
- a clinical and lung microbiota profile of patients with COPD;
- a model of AECOPD prediction;
- recommendations for community-based PR in AECOPD;
- a CDMT to prioritise patients with AECOPD for PR.
PRIME will contribute to optimise outcomes, improve AECOPD healthcare services and reduce the burden with COPD.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR.
| Arm | Type | Receives |
|---|---|---|
| Pulmonary rehabilitation | Experimental | Other: Pulmonary rehabilitationPulmonary rehabilitation will be provided to every patient that accepts the intervention and presents an acute exacerbation |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are eligible if adults (≥18anos) and present a diagnose of chronic obstructive pulmonary disease (COPD).
Key exclusion criteria (1 listed)
- Patients will be excluded if they had an acute cardiovascular event on the previous month or if they have a significant cardiac, immune, musculoskeletal or neurological impairment, or any other that doesn't allow them to perform tests.
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 |
|---|---|---|
| Pulmonary rehabilitationPulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support. | Other | Pulmonary rehabilitation |
Primary outcome
Change in exercise tolerance
Time frame: Up to 6 months
exercise tolerance in a walking field test
Change in lung microbiota
Time frame: Up to 6 months
lung microbiota from saliva samples
11 secondary outcomes
Change in muscle strength
Time frame: Up to 6 months
Change in health related Quality of life
Time frame: Up to 6 months
Change in resting dyspnoea
Time frame: Up to 6 months
Change in self-efficacy
Time frame: Up to 6 months
Change in physical activity
Time frame: Up to 6 months
Change in lung function
Time frame: Up to 6 months
Change in emergency department visits
Time frame: Up to 6 months
Change in frequency of exacerbations
Time frame: Up to 6 months
Change in hospitalizations
Time frame: Up to 6 months
Dyspnoea during exercise
Time frame: Up to 6 months
Fatigue during exercise
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Derived from this study: PubMed 35514131Cross AJ, Thomas D, Liang J, Abramson MJ, George J, Zairina E. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care. Cochrane Database Syst Rev. 2022 May 6;5(5):CD012652. doi: 10.1002/14651858.CD012652.pub2.
- Individual participant dataSharing planned: No
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
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.
Alda Marques, PhD principal investigator
School of Health Sciences, University of Aveiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary rehabilitation in people with COPD Exacerbation and COPD, run by Aveiro University at 1 site in Portugal.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Jul 2020. 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 Portugal. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alda Marques, PhD (00351 234 372 462 ext. 27121, amarques@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise tolerance (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03701945, which also lists 1 linked publication.
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 8 Jul 2020.