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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06097507
Other study ID # 2024-10072
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 7, 2023
Est. completion date June 2024

Study information

Verified date March 2024
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact Nicole EZER, MD
Phone (514)-934-1934
Email nicole.ezer@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Canada McGill University Health Center Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rotation of Ventolin MDI to Bricanyl Turbuhaler. Proportion of participants who changed their inhaler from Ventolin MDI to Bricanyl Turbuhaler within 30 days of study visit. 30 days
Secondary Rate of failure of the intervention defined as a rotation back from Bricanyl to Ventolin MDI within 90 days after the clinic 90 days
Secondary Proportion of patients who filled Bricanyl Rx change 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
Secondary Awareness of patients regarding the climate impact of inhalers 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
Secondary Patients' willingness to change inhalers for environmental reasons 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
Secondary Providers' willingness to change inhalers for environmental reasons 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
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