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The study compares Buventol® Easyhaler® and Bufomix® Easyhaler® to the current standard treatment during methacholine challenge test. The trial will also provide inspiratory flow profile data for Easyhaler inhaler.
This trial is designed to provide a further evidence for the use of Easyhaler in diagnostic bronchial challenge tests and on the use of Easyhaler inhaler during obstructive event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buventol® Easyhaler® 200 µg/inhalation dmDPI | Experimental | 400 μg of salbutamol from Buventol Easyhaler is administered as two inhalations. |
|
| Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI | Experimental | 320 μg of budesonide and 9 μg of formoterol are administered from Bufomix Easyhaler as two inhalations. |
|
| Ventoline® Evohaler® 100 µg/inhalation pMDI | Active Comparator | 400 μg of salbutamol from Ventoline Evohaler is administered via Volumatic spacer as four inhalations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buventol® Easyhaler® 200 µg/inhalation dmDPI | Drug | Two doses will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) | Mean change in FEV1 from post-diluent to FEV1 after the first dose of reliever. | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who recover from bronchoconstriction after first dose | Proportion of the subjects who recover to FEV1 > -10% compared to post-diluent FEV1 after first dose of reliever. | 10 minutes |
| Forced expiratory volume in one second (FEV1) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients needing medical attention | Proportion of subjects needing medical attention after study treatment | After study treatment administration until study completion (an average of 2.5 hours) |
| Inhalation profile via Easyhaler |
Inclusion Criteria:
Exclusion Criteria:
Subjects not eligible for methacholine challenge test for example for any of the following reasons:
Subjects who have used the following treatments before the study visit:
Known hypersensitivity to the active substance(s) or the excipients of the study treatments (for example severe milk allergy, lactose contains small amounts of milk protein).
Administration of another investigational medicinal product within 30 days before the study visit.
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| Name | Affiliation | Role |
|---|---|---|
| Lauri Lehtimäki | Tampere University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland | |||
| Tampere University Hospital |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Bufomix® Easyhaler® 160/4.5 µg/inhalation dmDPI | Drug | Two doses will be administered |
|
|
| Ventoline® Evohaler® 100 µg/inhalation pMDI | Drug | Four doses will be administered via Volumatic spacer |
|
|
Relative recovery of FEV1 after the study treatment dosing when compared to post-diluent FEV1.
| 10 minutes |
| Number of subjects who recover from bronchoconstriction after second dose | Proportions of subjects reaching FEV1 > -10% of post-diluent value after second dose of reliever. | 20 minutes |
Time-inspiratory flow -curve via Easyhaler measured with spirometer.
| Before methacholine challenge and 10 minutes after the subject experiences FEV1 drop ≥ 20% compared to post-diluent spirometry |
| Tampere |
| 33520 |
| Finland |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |