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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002370-30 | EudraCT Number |
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The study is aimed to assess the dose proportional total systemic exposure (when the administration is without the activated charcoal) to B17MP (active metabolite of BDP) and its lung bioavailability (when the administration is with the activated charcoal) after single inhalation of CHF 1535 NEXThaler DPI at two dose strengths.
At the same time, the study will assess if the lung deposition and the total systemic exposure to Formoterol is affected by increasing doses of BDP.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEXThaler 100/6 mcg DPI | Experimental | Single dose (4 inhalations)of NEXThaler 100/6 mcg DPI: total dose 400/24 mcg |
|
| NEXThaler 200/6 mcg DPI | Experimental | Single dose (4 inhalations)of NEXThaler 200/6 mcg DPI: total dose: 800/24 mcg |
|
| NEXThaler placebo | Placebo Comparator | Single dose (4 inhalations) |
|
| NEXThaler 100/6 mcg plus CB | Experimental | Single dose (4 inhalations) NEXThaler 100/6 mcg administered with activated charcoal (Charcoal Block): total dose 400/24 mcg |
|
| NEXThaler 200/6 mcg plus CB | Experimental | Single dose (4 inhalations) NEXThaler 200/6 mcg administered with activated charcoal (Charcoal Block): total dose 800/24 mcg |
|
| Flixotide Accuhaler 500 mcg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEXThaler 100/6 mcg DPI | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Formoterol AUC0-t and B17MP AUC0-t | from predose until 12 hr post dose |
| Measure | Description | Time Frame |
|---|---|---|
| BDP pharmacokinetic (PK) parameters | The following parameters will be evaluated: AUC0-t, AUC0-12h, AUC0-inf, Cmax, tmax, t1/2 | from predose until 12 hr post dose |
| Other PK parameter of B17MP and formoterol |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma glucose | the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmax and tmax | from predose until 12 hours postdose |
| Heart rate (HR) | the following parameters will be evaluated: HR AUC0-12/12h |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medicine Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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Single dose (2 inhalations) of fluticasone propionate |
|
| Flixotide Accuhaler 500 mcg | Drug | Active comparator |
|
|
| NEXThaler 200/6 mcg DPI | Drug |
|
|
| NEXThaler placebo | Drug | Placebo comparator |
|
the following pharmacokinetic parameters will be evaluated: AUC0-12, AUCinf, Cmax, tmax, t1/2
| from predose until 12 hours postdose |
| from predose until 12 hours postdose |
| Plasma cortisol | the following parameters will be evaluated: AUC0-24, Cmin and tmin | from predose until 24 hours postdose |
| Plasma potassium | the following parameters will be evaluated: AUC0-4h, AUC0-12h, Cmin ad tmin | from predose until 12 hours postdose |
| Systolic and Diastolic Blood Pressure (SBP and DBP) | the following parameters will be evaluated: SBP AUC0-12/12h and DBP AUC0-12/12h | from predose until 12 hours postdose |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068759 | Formoterol Fumarate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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