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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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Double-blind, randomized, two-way cross-over study with two treatment periods. 28 subjects with asthma will be randomized in 1:1 ratio to treatment A) Indacaterol/Mometasone 150/160 μg once daily and treatment B) Indacaterol/Glycopyrronium/Mometasone 150/50/80 μg once daily for period 1. For period 2, subjects will be crossed over to the other treatment arm. Subjects will be screened during the first visit. After inclusion subjects will be seen for 3 visits during the Run-in period, 3 visits during treatment period 1 and 3 visits during treatment period 2. During these visits patients will be clinically characterized and exposed to allergen challenge tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QMF149 | Active Comparator | Mometasone furoaat / Indacaterol |
|
| QVM149 | Experimental | Mometasone furoaat / Indacaterol / Glycopyrronium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVM149 | Drug | Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol |
|
| Measure | Description | Time Frame |
|---|---|---|
| % of sputum eosinophils | Percentage of sputum eosinophils | 24 hours after allergen challenge at the end of each treatment period vs. control allergen challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarten Van den Berge, Dr. | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713GZ | Netherlands |
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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 |
|---|---|
| D000068656 | Mometasone Furoate |
| C000600413 | QMF149 |
| C510790 | indacaterol |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Double-blind, randomized, two-way cross-over study with two treatment periods.
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| QMF149 | Drug | Mometasone / Indacaterol |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |