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This is a retrospective, multicentre, non-interventional, observational study in patients with asthma and/or COPD who are treated with budesonide-formoterol.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide-Formoterol | Drug | Dry powder inhaler |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control | The number of asthma and/or COPD exacerbations during the 12 months pre-switch and the 12 months post-switch. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Training at pharmacy |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient has declined participation in the study or failed to respond to the invitation to participate.
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Patients with asthma and/or COPD treated with budesonide-formoterol DPI
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| Name | Affiliation | Role |
|---|---|---|
| Jorn Ossum | Flattum Legesenter | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flattum Legesenter | Hønefoss | Norway |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 15, 2022 | |
| Reset | Mar 30, 2023 | |
| Release | Apr 25, 2023 | |
| Reset | Jan 5, 2024 | |
| Release | Feb 1, 2024 | |
| Reset | Jul 17, 2024 | |
| Release | Mar 18, 2025 | |
| Reset | Apr 3, 2025 | |
| Release | Apr 3, 2025 | |
| Reset | Apr 22, 2025 | |
| Release | Apr 23, 2025 | |
| Reset | May 8, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 15, 2022 | Mar 30, 2023 | |||
| Apr 25, 2023 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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The correlation between inhaler training given at pharmacy and exacerbations.
| 24 months |
| 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 |
| Inhaler switch | The number of re-switches after the first 'eligible' switch and the reasons for that switch. | 24 months |
| Jan 5, 2024 |
| Feb 1, 2024 | Jul 17, 2024 |
| Mar 18, 2025 | Apr 3, 2025 |
| Apr 3, 2025 | Apr 22, 2025 |
| Apr 23, 2025 | May 8, 2025 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D019819 | Budesonide |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |