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

Terminated

• Conditions: Asthma; COPD

• Registration Number: NCT04663386
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-12-04
• Study First Submitted QC: 2020-12-04
• Study Start: 2020-12-10
• Study First Posted: 2020-12-11
• Status Verified: 2021-09
• Primary Completion: 2021-09-14
• Study Completion: 2021-09-14
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease control	24 months	The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch.

Secondary Outcome Measures

Name	Time	Method
Budesonide-formoterol dose	24 months	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).
Training at pharmacy	24 months	The correlation between inhaler training given at pharmacy and exacerbations.
Healthcare utilisation	24 months	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.
Inhaler switch	24 months	The number of re-switches after the first 'eligible' switch and the reasons for that switch.

Trial Locations

Locations (1)

Flattum Legesenter; 🇳🇴 Hønefoss, Norway