Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway

Asthma Clinical Trial

— BufoSwitch  

Official title:

Switch of Budesonide-formoterol Dry Powder Inhalers at Pharmacy in Norway; A Retrospective, Observational Study to Evaluate the Impact on Disease Control in Patients With Asthma and/or Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04663386
• Other study ID #: 3103018
• Status: Terminated
• Start date: December 10, 2020
• Est. completion date: September 14, 2021

Study information

• Verified date: September 2021
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.

Description:

In July 2018 Norwegian authorities decided to allow switch at pharmacy for dry powder inhalers (DPIs) containing budesonide-formoterol. Pharmacists are instructed to switch patients to the inhaler with the lowest price. The pharmacist will train the patient on how to use the new inhaler. All patients whose eligible inhaler switch occurred between 1st July 2018 and 1st March 2019 will be eligible for the study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

1. Written informed consent has been obtained.

2. Male or female patients with a diagnosis of asthma and/or COPD whose budesonide-formoterol DPI was switched to another budesonide-formoterol DPI at pharmacy between 1st July 2018 and 1st March 2019 (referred to as the eligible switch).

3. Age =12 years at time of switch.

4. Treated with budesonide-formoterol for at least 12 months before the eligible switch (pre-switch period) and 12 months after the eligible switch (post-switch period). Re-switch(es) of inhaler are allowed during the post-switch period.

Exclusion Criteria:

1. Patient has declined participation in the study or failed to respond to the invitation to participate.

Related Conditions & MeSH terms

• Asthma
• COPD

Intervention

Drug:
• Budesonide-Formoterol
Dry powder inhaler

Locations

Country	Name	City	State
Norway	Flattum Legesenter	Hønefoss

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease control	The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch.	24 months
Secondary	Budesonide-formoterol dose	The change in the treatment dose of budesonide-formoterol at the time of the eligible switch and at the end of the post-switch period (e.g. 12 months post-switch).	24 months
Secondary	Training at pharmacy	The correlation between inhaler training given at pharmacy and exacerbations.	24 months
Secondary	Healthcare utilisation	The number of asthma and/or COPD related hospitalisations, emergency room visits and visits to physicians 12 months pre-switch and 12 months post-switch.	24 months
Secondary	Inhaler switch	The number of re-switches after the first 'eligible' switch and the reasons for that switch.	24 months