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

NCT04663386 — Terminated, 29 participants, Orion Corporation, Orion Pharma

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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)

Registry	NCT04663386, acronym BufoSwitch
Status	Terminated - Target recruitment not reached
Study type	Observational
Enrollment	29 (Actual)
Sponsor	Orion Corporation, Orion Pharma (Industry)
Conditions	Asthma, COPD
Interventions	Budesonide-Formoterol (Drug)
Dates	start 2020-12-10, primary completion 2021-09-14, completion 2021-09-14, first posted 2020-12-11, last updated 2021-09-23
Locations	1 site in Norway

-Summary

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

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+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.

+Arms and interventions

Budesonide-Formoterol (Drug): Dry powder inhaler

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 12 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Flattum Legesenter	Hønefoss	Norway

+Investigators

Jorn Ossum, Principal investigator, Flattum Legesenter