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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002939-25 | EudraCT Number |
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The purpose of this study is to assess the the ability of a single dose of LAS40468 administered via Genuair® and a single dose of salmeterol/fluticasone propionate (Seretide®) administered via Accuhaler to produce bronchodilation (opening of the airways) and the safety and tolerability of the treatments
This is a Phase 1, randomised, double-blind, double-dummy, cross-over trial to assess the bronchodilation effect of a single dose of LAS40468 and a single dose of salmeterol/fluticasone propionate (Seretide®) administered to adult patients with stable asthma.
The study will consist of a screening visit and treatment periods of approximately 13 hours separated by washout periods of 7 to 14 days from the time of Investigational Medicinal product (IMP) administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS40468 | Experimental | Single dose, administered via Genuair® dry powder inhaler (DPI) |
|
| Salmeterol/fluticasone propionate | Active Comparator | Single dose, Seretide® (salmeterol fluticasone propionate) administered via Accuhaler™ |
|
| Placebo | Placebo Comparator | Single dose administered via Genuair® or Accuhaler™ dry powder inhaler (DPI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS40468 | Drug |
| ||
| Salmeterol/fluticasone propionate |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline (pre-dose at each period) in normalised forced expiratory volume in 1 second (FEV1) area under the curve (AUC) over the 12 hour period after IMP administration (AUC0-12) | 12 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | An adverse event (AE) is any untoward medical occurrence in a clinical trial subject (regardless of the administration of the IMP and the causal relationship to it). An AE can therefore be any unfavourable and unintended medical occurrence during subject's participation in the trial, including deterioration of a pre-existing medical, an ECG abnormality, a blood pressure abnormal value or an abnormal finding in the physical examination. A Serious AE is any AE that: results in death, is life-threatening, requires hospitalisation or prolongs existing hospitalisation, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is any other medically important event that may jeopardise the subject or may require intervention to prevent one of the other above outcomes. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious AE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site #1 | Berlin | 14050 | Germany | |||
| Almirall Investigational Site #2 |
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|
| Placebo | Drug |
|
| 7-9 weeks |
| Harrow |
| HA1 3UJ |
| United Kingdom |
| 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 |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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