COPDPhase 4NCT02136875
Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation
A Phase 4 study testing Double dose of Salmeterol + Fluticasone Propionate, Self-management education on the use of a self-administered prescription for exacerbation. and Self-administered prescription in people with COPD and Chronic Obstructive Pulmonary Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Double dose of Salmeterol + Fluticasone Propionate, Self-management education on the use of a self-administered prescription for exacerbation. and Self-administered prescription
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2008to Aug 2010
- Phase
- Phase 4
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stable COPD;
- 40 years or older;
- Smoking history of at least 10 pack-years;
- Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70;
- Dyspnea ≥ 2 on the Medical Research Council (MRC) scale;
- At least 2 exacerbations requiring prednisone treatment in the past 3 years;
- Using a written action plan and having demonstrated adequate use of the self-administered antibiotic \& prednisone (adequate use defined as prednisone started by the patient within 72 hours of symptom worsening and patient called the case-manager as recommended for following the response);
- Already on Advair BID (twice a day) as a maintenance therapy or able to switch over to Advair if already taking another combination medication (Symbicort) as maintenance therapy for COPD.
Who cannot join
- History of asthma or allergic rhinitis before the age of 40;
- Regular use of oxygen, oral corticosteroids, antibiotics;
- Unstable or life threatening co-morbid condition;
- Medical conditions or taking medications known to affect tremor and/or heart rate (HR).
- Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole));
- On theophyllines.
- Colonized with pseudomonas aeruginosa.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study; Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation
The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.
Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.
Read more
Secondary objectives:
- To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;
- To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;
- To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).
Read the detailed description
BACKGROUND Acute exacerbations of COPD (AECOPD) are of major importance since they are associated with adverse effects on morbidity, health status, and costs. Conventional treatment includes the use of antibiotics and oral corticosteroids (OCS). However, OCS is associated with significant side effects. This is of considerable importance since exacerbation occurs on average 2 to 4 times per year in COPD patients. Alternative treatment such as high dose inhaled corticosteroids has also been shown to be effective in the treatment of AECOPD. Recently, studies have clearly demonstrated the effect of combination therapy (SFP) on key inflammatory cells and a marked enhance anti-inflammatory effect when compared to inhaled corticosteroids alone. Inhaled corticosteroids have a high level of topical anti-inflammatory activity and a low level of systemic. Additionally, combination therapy with inhaled corticosteroids and long-acting β2-adrenoceptor agonists (SFP) appears to produce significant anti-inflammatory effects in COPD airways that are not seen when inhaled or oral steroids are used alone. This could offer a potential for an alternative treatment to oral corticosteroids in AECOPD.
RATIONALE None of the inhaled treatments is likely to be adopted and to replace the use of OCS for the treatment of AECOPD unless it is used promptly at the onset of symptom worsening. Early treatment has been shown to have clinical importance in accelerating symptom recovery and reducing hospital admission. Recently, the investigators have demonstrated that the early treatment of AECOPD can be achieved by the implementation of a written action plan as part of a self-management education.
The use of action plans helps COPD patients recognize symptom changes, implement self-care and self-initiate a customized prescription (antibiotics \& oral steroids) in the event of an exacerbation. Self-management education programs with a written action plan that includes standing prescriptions with combination therapy (SFP) in the event of an exacerbation may be promising in reducing the use of prednisone in AECOPD, the conventional treatment.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- Double dose of Salmeterol + Fluticasone Propionate, Self-management education on the use of a self-administered prescription for exacerbation., Self-administered prescription
- Keywords
- COPD, COPD exacerbation
- 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.
Double dose of Salmeterol + Fluticasone PropionateDrug
Also called Advair
Self-management education on the use of a self-administered prescription for exacerbation.Behavioural
Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription.
Self-administered prescriptionDrug
An Acute Exacerbation of COPD (AECOPD) is defined as a sustained worsening of dyspnea, cough or sputum production leading to an increase in the use of maintenance medication and/or supplementation with additional medication. In addition, exacerbations should be defined as either purulent or non-purulent.
Standing prescriptions for exacerbation:
- Purulent exacerbation - Antibiotic: Avelox 400 mg daily for 5 days. 2a) Mild to moderate exacerbation - Combination therapy (SFP - Advair) to be increased as follows: If regular treatment is Advair 250/50 BID then dose should be increased to Advair 500/100 BID for 10 days; if regular treatment is Advair 500/50 BID then increase to Advair 1000/100 BID for 10 days.
2b) Severe exacerbation - Prednisone (oral): 40 mg once daily for 7-10 days
| Study group | Role | What they receive |
|---|---|---|
| Double dose of Advair for AECOPD | Experimental | Double dose of Salmeterol + Fluticasone Propionate (Advair) Self-administered prescription Self-management education on the use of a self-administered prescription Receives: Drug: Double dose of Salmeterol + Fluticasone Propionate; Behavioral: Self-management education on the use of a self-administered prescription for exacerbation.; Drug: Self-administered prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with treatment success (no need of prednisone)
The primary outcome measure of the pilot study will be "treatment success" defined as "no need of prednisone within 30 days of the onset (worsening of dyspnea) on a mild to moderate acute exacerbation of COPD".
Measured: within 30 days from the onset of an acute exacerbation of COPD
Secondary outcomes (7)
Change from baseline in Quality of life as measured by the St Georges Respiratory Questionnaire
Measured: at 30 days from onset of an acute exacerbation of COPD
Percentage of patients who used healthcare resources (visits to Doctor and visits to the COPD nurse)
Measured: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who presented Cardiovascular Events
Any cardiovascular events captured at any medical visit or hospital visit within 30 days of onset of an acute exacerbation
Measured: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who presented any Adverse Events
Measured: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who developed Pneumonia
Measured: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients with ER admissions
Measured: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who had any Hospital admissions
Measured: within 30 days from onset of an acute exacerbation of COPD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJul 2008
- Primary completionAug 2010
- Study completionAug 2010
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 COPDStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jean Bourbeau, MD, FRCPC, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136875
- Sponsor's protocol ID
- BMC-08-001
- Status last verified
- May 2014
- First submitted
- 29 Apr 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bourbeau J, Sedeno MF, Metz K, Li PZ, Pinto L. Early COPD Exacerbation Treatment with Combination of ICS and LABA for Patients Presenting with Mild-to-Moderate Worsening of Dyspnea. COPD. 2016 Aug;13(4):439-47. doi: 10.3109/15412555.2015.1101435. Epub 2016 Jan 11.
PubMed 26752024
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study; Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation
- ClinicalTrials.gov ID
- NCT02136875
- Acronym / sponsor ID
- BMC-08-001
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, COPD exacerbation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 13 May 2014 (estimated)
- 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.
The purpose of this pilot study is to determine whether early treatment of acute exacerbations of chronic obstructive pulmonary disease (AECOPD) with a combination therapy, Salmeterol + Fluticasone Propionate (SFP - Advair) will reduce the use of prednisone, known as the conventional treatment.
Primary objective: To determine whether early treatment with combination therapy (SFP) can reduce the use of prednisone (the conventional treatment) in the event of an AECOPD.
Secondary objectives:
- To evaluate the feasibility of this treatment approach and to provide pilot data (needed for a larger multi-centre clinical trial;
- To evaluate the feasibility and need of assessment during and after exacerbation onset, health-related quality of life and physical activity;
- To evaluate the safety of this approach; this is in terms of the delay in starting prednisone and an unfavourable outcome (ER visits and/or hospitalization).
Detailed description
BACKGROUND Acute exacerbations of COPD (AECOPD) are of major importance since they are associated with adverse effects on morbidity, health status, and costs. Conventional treatment includes the use of antibiotics and oral corticosteroids (OCS). However, OCS is associated with significant side effects. This is of considerable importance since exacerbation occurs on average 2 to 4 times per year in COPD patients. Alternative treatment such as high dose inhaled corticosteroids has also been shown to be effective in the treatment of AECOPD. Recently, studies have clearly demonstrated the effect of combination therapy (SFP) on key inflammatory cells and a marked enhance anti-inflammatory effect when compared to inhaled corticosteroids alone. Inhaled corticosteroids have a high level of topical anti-inflammatory activity and a low level of systemic. Additionally, combination therapy with inhaled corticosteroids and long-acting β2-adrenoceptor agonists (SFP) appears to produce significant anti-inflammatory effects in COPD airways that are not seen when inhaled or oral steroids are used alone. This could offer a potential for an alternative treatment to oral corticosteroids in AECOPD.
RATIONALE None of the inhaled treatments is likely to be adopted and to replace the use of OCS for the treatment of AECOPD unless it is used promptly at the onset of symptom worsening. Early treatment has been shown to have clinical importance in accelerating symptom recovery and reducing hospital admission. Recently, the investigators have demonstrated that the early treatment of AECOPD can be achieved by the implementation of a written action plan as part of a self-management education.
The use of action plans helps COPD patients recognize symptom changes, implement self-care and self-initiate a customized prescription (antibiotics \& oral steroids) in the event of an exacerbation. Self-management education programs with a written action plan that includes standing prescriptions with combination therapy (SFP) in the event of an exacerbation may be promising in reducing the use of prednisone in AECOPD, the conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Double dose of Advair for AECOPD | Experimental | Drug: Double dose of Salmeterol + Fluticasone Propionate, Behavioral: Self-management education on the use of a self-administered prescription for exacerbation., Drug: Self-administered prescriptionDouble dose of Salmeterol + Fluticasone Propionate (Advair) Self-administered prescription Self-management education on the use of a self-administered prescription |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of stable COPD;
- 40 years or older;
- Smoking history of at least 10 pack-years;
- Forced Expiratory Volume in one second (FEV1) ≤ 70 % of predicted value and FEV1 / Forced Vital Capacity (FVC) < 0.70;
- Dyspnea ≥ 2 on the Medical Research Council (MRC) scale;
Key exclusion criteria (7 listed)
- History of asthma or allergic rhinitis before the age of 40;
- Regular use of oxygen, oral corticosteroids, antibiotics;
- Unstable or life threatening co-morbid condition;
- Medical conditions or taking medications known to affect tremor and/or heart rate (HR).
- Pre-existing medical conditions or on concomitant medications contraindicated with salmeterol or fluticasone propionate (e.g. monoamine oxidase inhibitors and tricyclic antidepressants, beta-adrenergic receptor blocking agents, non potassium-sparing diuretics, inhibitors of cytochrome P450 (ritonavir, ketoconazole));
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 |
|---|---|---|
| Double dose of Salmeterol + Fluticasone PropionateAlso: Advair | Drug | Double dose of Advair for AECOPD |
| Self-management education on the use of a self-administered prescription for exacerbation.Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription. | Behavioural | Double dose of Advair for AECOPD |
| Self-administered prescriptionAn Acute Exacerbation of COPD (AECOPD) is defined as a sustained worsening of dyspnea, cough or sputum production leading to an increase in the use of maintenance medication and/or supplementation with additional medication. In addition, exacerbations should be defined as either purulent or non-purulent. Standing prescriptions for exacerbation: 1) Purulent exacerbation - Antibiotic: Avelox 400 mg daily for 5 days. 2a) Mild to moderate exacerbation - Combination therapy (SFP - Advair) to be increased as follows: If regular treatment is Advair 250/50 BID then dose should be increased to Advair 500/100 BID for 10 days; if regular treatment is Advair 500/50 BID then increase to Advair 1000/100 BID for 10 days. 2b) Severe exacerbation - Prednisone (oral): 40 mg once daily for 7-10 days | Drug | Double dose of Advair for AECOPD |
Primary outcome
Percentage of participants with treatment success (no need of prednisone)
Time frame: within 30 days from the onset of an acute exacerbation of COPD
The primary outcome measure of the pilot study will be "treatment success" defined as "no need of prednisone within 30 days of the onset (worsening of dyspnea) on a mild to moderate acute exacerbation of COPD".
7 secondary outcomes
Change from baseline in Quality of life as measured by the St Georges Respiratory Questionnaire
Time frame: at 30 days from onset of an acute exacerbation of COPD
Percentage of patients who used healthcare resources (visits to Doctor and visits to the COPD nurse)
Time frame: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who presented Cardiovascular Events
Time frame: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who presented any Adverse Events
Time frame: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who developed Pneumonia
Time frame: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients with ER admissions
Time frame: within 30 days from onset of an acute exacerbation of COPD
Percentage of patients who had any Hospital admissions
Time frame: within 30 days from onset of an acute exacerbation of COPD
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 14 May 2014.
- Derived from this study: PubMed 26752024Bourbeau J, Sedeno MF, Metz K, Li PZ, Pinto L. Early COPD Exacerbation Treatment with Combination of ICS and LABA for Patients Presenting with Mild-to-Moderate Worsening of Dyspnea. COPD. 2016 Aug;13(4):439-47. doi: 10.3109/15412555.2015.1101435. Epub 2016 Jan 11.
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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.
Jean Bourbeau, MD, FRCPC principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Double dose of Salmeterol + Fluticasone Propionate, Self-management education on the use of a self-administered prescription for exacerbation. and Self-administered prescription in people with COPD and Chronic Obstructive Pulmonary Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 8 inclusion and 7 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 14 May 2014. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of participants with treatment success (no need of prednisone) (time frame: within 30 days from the onset of an acute exacerbation of COPD). 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 NCT02136875, 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 14 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.