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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023281-47 | EudraCT Number |
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The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.
The primary objective is to demonstrate that CHF 1535 NEXT DPI® (beclomethasone dipropionate + formoterol fumarate 100/6 μg), 1 inhalation twice daily, is non-inferior to the corresponding dose of CHF 1535 pMDI in terms of pulmonary function test (change from baseline to the entire treatment period in average pre-dose morning PEF) in asthmatic adult patients ≥ 18 years under treatment with fixed dose combination of Foster® (beclomethasone dipropionate + formoterol fumarate 100 / 6 μg) 1 inhalation bid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 1535 100/6 NEXT Dry Powder Inhaler® | Experimental | CHF1535 100/6 NEXT DPI® 1 inhalation bis in day (b.i.d) (daily dose BDP 200/FF 12 µg) |
|
| CHF1535 100/6 pMDI | Active Comparator | CHF1535 100/6 pressurisedMeterDoseInhaler 1 inhalation b.i.d (total daily dose BDP 200/FF 12 µg) |
|
| beclomethasone dipropionate DPI | Active Comparator | beclomethasone dipropionate 100 µg DPI, 1 inhalation b.i.d (total daily dose BDP 200 µg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 1535 100/6 NEXT DPI® 2 months | Drug | CHF 1535 100/6 NEXT DPI® 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to the entire treatment period in average pre-dose morning Peak Expiratory Flow. | at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-dose morning FEV1 (Forced Expiratory Volume in one second); | at 2, 4, 6 and 8 weeks of treatment | |
| Pre-dose morning FVC (Force Vital Capacity) ; | at 2, 4, 6 and 8 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank KANNIESS, Dr | Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSPZOZ Uniwersytecki Szpital Kliniczny | Lodz | 90-153 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25088067 | Result | Kanniess F, Scuri M, Vezzoli S, Francisco C, Petruzzelli S. Extrafine beclomethasone/formoterol combination via a dry powder inhaler (NEXThaler((R))) or pMDI and beclomethasone monotherapy for maintenance of asthma control in adult patients: A randomised, double-blind trial. Pulm Pharmacol Ther. 2015 Feb;30:121-7. doi: 10.1016/j.pupt.2014.07.006. Epub 2014 Aug 1. |
| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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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 |
|---|---|
| D005581 | Foster Home Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| CHF 1535 100/6 pMDI 2 months | Drug | CHF 1535 100/6 pMDI 2 months |
|
|
| BDP DPI 2 months | Drug | BDP DPI 2 months |
|
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| ACQ (Asthma Control Questionnaire) score ; |
| at eight weeks |
| pre-dose evening PEF ; | at 2, 4, 6 and 8 weeks of treatment |
| daily PEF variability ; | at 2, 4, 6 and 8 weeks of treatment |
| use of rescue medication ; | at 2, 4, 6 and 8 weeks of treatment |
| percentage of rescue use-free days | at 2, 4, 6 and 8 weeks of treatment |
| pre-dose morning PEF ; | at 2, 4, 6 and 8 weeks of treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D005159 |
| Health Care Facilities Workforce and Services |