FreeDom Strategy for COPD Exacerbations
Recruiting in Palo Alto (17 mi)
Overseen byFrançois Lellouche
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Laval University
Disqualifiers: Sleep apnea, NIV at home, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The main objective of the study is to assess the "FreeDom" innovative strategy (FreeO2 at Domicile) to reduce hospitalization duration in patients with COPD exacerbation. This strategy associates early hospital discharge, automated O2 flow weaning with FreeO2 system, telemedicine and tele-rehabilitation.
The main hypothesis of this study is that the FreeDom strategy will reduce the number of hospitalization day by 50 percent at day 30.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the FreeDom treatment for COPD exacerbations?
The research highlights the importance of placebo-controlled trials in determining the effectiveness of treatments for COPD. Although specific data on the FreeDom treatment is not provided, the studies emphasize the need for strong evidence showing a treatment's superiority over placebo before considering it effective.
12345Is the FreeDom Strategy for COPD Exacerbations safe for humans?
The available research does not provide specific safety data for the FreeDom Strategy for COPD Exacerbations, but it does mention that serious adverse events, including pneumonia, were more frequent in a related study. This suggests that while the treatment may be safe for some, there could be risks involved, and it's important to discuss these with a healthcare provider.
46789How does the Control treatment for COPD exacerbations differ from other treatments?
The Control treatment, which involves a placebo or standard care, is unique because it serves as a baseline to compare the effectiveness of other treatments in clinical trials, rather than providing a direct therapeutic effect itself.
24101112Eligibility Criteria
This trial is for COPD patients needing moderate oxygen therapy (<6L/min) to maintain SpO2 > 90%, hospitalized for less than 48 hours, aged over 40 with a history of smoking. It's not for those non-autonomous and alone at home, refusing consent, needing imminent intubation, with sleep apnea or living far from the hospital (>50 km).Inclusion Criteria
I need less than 6L/min of oxygen to keep my oxygen levels above 90%.
I am 40 years old or older.
I was hospitalized for a severe COPD flare-up but stayed less than 48 hours.
+3 more
Exclusion Criteria
Patient already included in the study within 3 months
A lung doctor thinks that you will need a breathing tube very soon.
I need help with daily activities and live alone.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Initial Hospitalization
Participants undergo initial conventional hospitalization with automated O2 flow rate titration by FreeO2 system
Up to 30 days
Home Hospitalization
Participants receive home hospitalization with automated oxygen flow titration, telemedicine, and tele-rehabilitation
Approximately 1 week
Follow-up
Participants are monitored for safety and effectiveness after treatment, including consultations and quality of life assessments
3 months
Participant Groups
The 'FreeDom' strategy is being tested to cut hospital stays by half in COPD exacerbation cases. It includes early discharge, automated O2 weaning using FreeO2 system, telemedicine and tele-rehabilitation.
2Treatment groups
Experimental Treatment
Active Control
Group I: ControlExperimental Treatment1 Intervention
The intervention is an hospitalization with usual care. The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
Group II: FreeDomActive Control1 Intervention
FreeDom strategy (early discharge, automated weaning at home, telemedicine, telereadaptation):
-initial conventional hospitalization before discharge home, O2 flow rate automatically titrated by FreeO2 (based on a SpO2 target). The hospital discharge will be possible if the definite criteria are met.
After hospital discharge, patient will have home hospitalisation. Automated oxygen flow titration, patient education will be conducted for using the telemedicine system, for questionnaires and for the tele-rehabilitation program will be initiated for home hospitalization,
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Institut Universitaire de Cardiologie et de Pneumologie de QuébecQuebec, Canada
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Who Is Running the Clinical Trial?
Laval UniversityLead Sponsor
References
The placebo effect in asthma drug therapy trials: a meta-analysis. [2019]A meta-analysis of randomized controlled asthma drug therapy trials published in the English literature from January 1991 to June 1995 was performed to estimate the magnitude and direction of the placebo effect in stable ambulatory asthmatic patients. Among placebo groups, the mean absolute increase in forced expiratory volume in 1 sec (FEV1), weighted for sample size and variance, was 0.11 L/min, and the mean percent increase in FEV1 was 4.81%. The corresponding placebo group changes in peak expiratory flow (PEF) were in an opposite direction to those of FEV1; there was a mean absolute decrease of 2.24 L/min, and a mean percent decrease of 4.21%. Changes for active treatment groups were greater in magnitude. However, there were no statistically significant differences in mean changes comparing the placebo groups to the treatment groups, for any of the outcome measures. Mean increases in PEF and FEV1 exceeded 10% in 5 of 33 placebo groups, as compared to 13 of 33 active treatment groups. In conclusion, in well-designed long-term drug therapy studies in stable asthmatics the pooled placebo effect is small but measurable, with FEV1 and PEF showing different directions of response. Moreover, a modest number of patients receiving placebo have changes in pulmonary function that might be interpreted as clinically significant.
Multicentre randomised placebo-controlled trial of inhaled fluticasone propionate in patients with chronic obstructive pulmonary disease. International COPD Study Group. [2022]The efficacy of inhaled corticosteroids in the treatment of chronic obstructive pulmonary disease (COPD) remains controversial because of a lack of placebo-controlled studies. We compared the effect of inhaled fluticasone propionate with placebo in the treatment of patients with COPD.
Where is the supporting evidence for treating mild to moderate chronic obstructive pulmonary disease exacerbations with antibiotics? A systematic review. [2018]Randomised trials comparing different drugs head-to-head are extremely valuable for clinical decision-making. However, it is scientifically and ethically sensible to demand strong evidence that a drug is effective by showing superiority over a placebo before embarking on head-to-head comparisons of potentially ineffective drugs. Our aim was to study the evolvement of evidence from placebo-controlled and head-to-head trials on the effects of antibiotics for the treatment of mild to moderate exacerbations of chronic obstructive pulmonary disease.
Premature discontinuation during the UPLIFT study. [2015]Placebo-controlled clinical trials on COPD are characterized by premature discontinuation. At present, no clear insight into this phenomenon is available.
Regular versus as-needed short-acting inhaled beta-agonist therapy for chronic obstructive pulmonary disease. [2013]Regular short-acting inhaled beta-agonist therapy is of uncertain benefit in patients with chronic obstructive pulmonary disease (COPD). We conducted a randomized, concealed, double-blind, placebo-controlled crossover trial in two periods, each of 3-mo duration, involving 53 patients with a smoking history of > 20 pack-years, an FEV1 of
Effectiveness versus efficacy trials in COPD: how study design influences outcomes and applicability. [2022]Guidelines for chronic obstructive pulmonary disease (COPD) management are based largely on results from double-blind randomised controlled trials (RCTs) of efficacy. These trials have high internal validity and test whether a drug is efficacious, but they are conducted in highly selected populations that may differ significantly from patients with COPD seen in routine practice.We compared the baseline characteristics, healthcare use and outcomes between the Salford Lung Study (SLS), an open-label effectiveness RCT, with six recent large-scale efficacy RCTs. We also calculated the proportion of SLS patients who would have been eligible for inclusion in an efficacy RCT by applying the inclusion criteria used in efficacy trials of combination treatments.SLS patients were older, included more females and more current smokers, had more comorbidities (including asthma), and had more often experienced exacerbations prior to inclusion. In the SLS, rates of moderate or severe exacerbations, incidence of overall serious adverse events (SAEs), and SAEs of pneumonia were more frequent. A maximum of 30% of patients enrolled in the SLS would have been eligible for a phase IIIa regulatory exacerbation study.Patients in large COPD efficacy RCTs have limited representativeness compared with an effectiveness trial. This should be considered when interpreting efficacy RCT outcomes and their inclusion into guidelines.
Correct use and ease-of-use of placebo ELLIPTA dry-powder inhaler in adult patients with chronic obstructive pulmonary disease. [2022]Inhaler technique errors are common in chronic obstructive pulmonary disease (COPD) treatment, potentially leading to poor disease management. Our pooled analysis approach assessed correct use and ease-of-use of a placebo ELLIPTA dry-powder inhaler (DPI) in patients with COPD.
Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. [2020]The impact of prior treatment on results of clinical trials in chronic obstructive pulmonary disease (COPD) has been debated. We used data from the Study to Understand Mortality and Morbidity in COPD Trial to examine the impact of prior treatment on the effects of randomised study drugs on mortality and exacerbations. We used data on 16 417 patients with moderate COPD and heightened cardiovascular risk and information on prior medications to examine the effects of fluticasone furoate (FF), vilanterol (VI) and combined FF/VI compared to placebo on moderate and severe exacerbation as well as mortality. The study was event-driven with a median study exposure of 1.8 years. This study was registered with ClinicalTrials.gov, number NCT01313676. There were no consistent associations between treatment prior to study entry and the effects of FF, VI or FF/VI on exacerbations during the study. However, patients taking inhaled corticosteroids and one or more bronchodilators prior to study entry seemed to have a better effect of active treatments than of placebo on mortality (hazard ratio for FF/VI 0.65, 95% CI 0.48-0.89). Survival in those randomised to placebo was independent of treatment prior to study enrolment. Prior treatment appears to affect treatment effects on mortality but not exacerbations in a randomised controlled trial of patients with COPD and heightened cardiovascular risk.
COPD mortality and exacerbations in the placebo group of clinical trials over two decades: a systematic review and meta-regression. [2022]A decreasing trend in exacerbation rates has been observed in COPD. Because mortality is linked to exacerbations, it is of interest to investigate whether a similar time trend is also present in mortality rates. We performed a systematic review of placebo groups in published randomised controlled trials. Mortality rate was modelled based on a Poisson distribution for the event counts. Adding information on mortality as well as on newly published studies on a previous database, we performed a meta-regression. Among the 56 included studies representing 14 166 patients, an annual decrease in mortality rates of 6.1% (-0.6%, 12.6%) (p=0.073) was observed. Consistent results were obtained in subgroups as well as when adjusting for potential confounders. The correlation between exacerbation rate and mortality rate was positive but weak as well as insignificant. In summary, analysis of randomised controlled trials in COPD patients showed a decrease in mortality in the placebo arms over the last two decades. This effect is comparable to the previously observed decrease in annual exacerbation rate. Albeit insignificant, our results suggest that care is needed in the design of new trials or when comparing results from trials published many years apart.
Spirometric changes in obstructive disease: after all, how much is significant? [2022]To establish the upper limits for changes in FEV1, slow vital capacity (SVC), FVC, and inspiratory capacity (IC) after placebo administration in patients with airflow obstruction.
Single-Inhaler Triple versus Dual Bronchodilator Therapy in COPD: Real-World Comparative Effectiveness and Safety. [2022]Randomized trials report that single-inhaler triple therapy is more effective than dual bronchodilators at reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). However, this effect may have been influenced by the forced withdrawal of inhaled corticosteroids (ICS) at randomization. We used an adaptive selection new-user design to compare single-inhaler triple therapy with dual bronchodilators in real-world clinical practice.
Efficacy and safety of oral corticosteroids to treat outpatients with acute exacerbations of COPD in primary care: a multicentre pragmatic randomised controlled study. [2023]To compare prednisone and placebo for the treatment of outpatients treated for acute exacerbations of chronic obstructive pulmonary disease (COPD) in a primary care setting.