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

Sponsor

Orion Corporation, Orion Pharma (Industry)

Overall Status

Terminated

CT.gov ID

NCT04663386

Collaborator

(none)

Enrollment

Location

9.1

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma COPD	Drug: 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 Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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)

Actual Study Start Date :

Dec 10, 2020

Actual Primary Completion Date :

Sep 14, 2021

Actual Study Completion Date :

Sep 14, 2021

Outcome Measures

Primary Outcome Measures

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

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 Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Written informed consent has been obtained.
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).
Age ≥12 years at time of switch.
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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Flattum Legesenter	Hønefoss		Norway

Sponsors and Collaborators

Orion Corporation, Orion Pharma

Investigators

Principal Investigator: Jorn Ossum, Flattum Legesenter

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Orion Corporation, Orion Pharma

ClinicalTrials.gov Identifier:

NCT04663386

Other Study ID Numbers:

3103018

First Posted:

Dec 11, 2020

Last Update Posted:

Sep 23, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Asthma

Budesonide

Formoterol Fumarate

Study Results

No Results Posted as of Sep 23, 2021