- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06097507
Patient Perspective on Climate Impact of Inhalers
Patient and Prescriber Perspective on Climate Impact of Inhalers in the Treatment of Asthma
The effects of climate change on population health have considerably increased as the planet warms and is thus subjected to more heat waves, extreme weather events and food insecurity. Paradoxically, healthcare systems are major contributors to carbon emissions.
Within the field of respirology, choice of inhaler is a low-hanging fruit to address this issue. Metered dose inhalers (MDI) contain potent greenhouse gases and have been shown to have a significantly larger carbon footprint than dry powder inhalers (DPI).
The goal of the study is to assess asthma patients' willingness to change inhalers for environmental reasons as well as prescribers' willingness to prescribe a different inhaler for environmental reasons at the patient's request. The study will also be assessing patient awareness of the climate impact of inhalers and the importance that they attribute to this issue as well as other issues (cost and ease of use).
Study Overview
Detailed Description
The effects of climate change on population health have considerably increased as the planet warms and is thus subjected to more heat waves, extreme weather events and food insecurity. Paradoxically, healthcare systems are major contributors to carbon emissions.
Within the field of respirology, choice of inhaler is a low-hanging fruit to address this issue. Metered dose inhalers (MDI) contain potent greenhouse gases and have been shown to have a significantly larger carbon footprint than dry powder inhalers (DPI).
Studies from the United Kingdom have revealed that although patient awareness of the discrepancy in climate impact of inhalers is low, their willingness to change inhalers after being educated on the subject is high.
An example of inhaler change is to use the Bricanyl Turbuhaler (terbutaline) instead of Ventolin (salbutamol) as a rescue medication in asthma. They are both short-acting bronchodilators (SABA) and have similar pharmacodynamics. However, use of Bricanyl for one year produces 7,183 kgCO2e or the equivalent of 59.9km by car, whereas use of Ventolin for one year produces 411,720 kgCO2e, the equivalent of 3,431 km by car.
The goal of the study is to assess asthma patients' willingness to change inhalers for environmental reasons as well as prescribers' willingness to prescribe a different inhaler for environmental reasons at the patient's request. The study will also be assessing patient awareness of the climate impact of inhalers and the importance that they attribute to this issue as well as other issues (cost and ease of use).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montréal, Quebec, Canada, H4A3J1
- McGill University Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Followed in the asthma clinic at the Montreal Chest Institute or the Montreal General Hospital.
- Confirmed diagnosis of asthma presenting for a follow up visit for their asthma (defined as positive methacholine challenge test or confirmed reversibility of lung function 12% increase FEV1 (forced expiratory volume) or 200ml absolute value increase post bronchodilator).
- On an inhaled steroid for the treatment of asthma for maintenance as well as Ventolin MDI as a rescue inhaler.
- Stable asthma -not currently being evaluated for an acute asthma exacerbation and no Emergency Room visits for asthma within the last 30 days.
- Adequate lung function with a FEV1 of at least 50% and, where available, a peak inspiratory flow (PIF) of under 60L/m for use of a DPI and MDI.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Asthma patients
Low risk educational intervention. The consented patients will be given an information packet containing an infographic about the climate impact of inhalers, a letter explaining the option of changing inhalers (which clearly outlines that the Bricanyl Turbuhaler will not cost them more money than the Ventolin) and a pre-filled prescription for Bricanyl Turbuhaler. Also 5 selected asthma providers will be asked to fill a questionnaire on their perspectives on the climate impact of inhalers and their approach to inhaler rotation. This may also be supplemented with a phone interview |
The consented patients will be given an information packet containing an infographic about the climate impact of inhalers, a letter explaining the option of changing inhalers (which clearly outlines that the Bricanyl Turbuhaler will not cost them more money than the Ventolin) and a pre-filled prescription for Bricanyl Turbuhaler.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rotation of Ventolin MDI to Bricanyl Turbuhaler.
Time Frame: 30 days
|
Proportion of participants who changed their inhaler from Ventolin MDI to Bricanyl Turbuhaler within 30 days of study visit.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of failure of the intervention
Time Frame: 90 days
|
defined as a rotation back from Bricanyl to Ventolin MDI within 90 days after the clinic
|
90 days
|
|
Proportion of patients who filled Bricanyl Rx change
Time Frame: 30 days
|
Proportion of patients who filled Bricanyl Rx change with pharmacist within 30 days of the clinic but did not possess the medication (30 day medication possession ratio)
|
30 days
|
|
Awareness of patients regarding the climate impact of inhalers
Time Frame: Baseline
|
Awareness of patients regarding the climate impact of inhalers defined by questionnaire data, using a 5 point likert scale (from "not at all aware" to "extremely aware")
|
Baseline
|
|
Patients' willingness to change inhalers for environmental reasons
Time Frame: Baseline
|
Patients' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients, using 3 different 5 point likert scale, one for each sub-category)
|
Baseline
|
|
Providers' willingness to change inhalers for environmental reasons
Time Frame: 6 months
|
Providers' willingness to change inhalers for environmental reasons and the importance of different issues (environmental impact, cost, ease of use) for patients. This will be assessed through 5 different 5 points likert scale, as well as with a phone interview. |
6 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-10072
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
product manufactured in and exported from the U.S.
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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