Caucasian males between 18 and 65 years of age (both inclusive) with the diagnose of persistent asthma for at least 6 months prior to screening, who are otherwise in good general physical health MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: LAS 100977
Product Code: LAS 100977
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor code: LAS100977
Concentration unit: µg microgram(s)
Concentration type: equal
Con
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Adult male subjects aged 18-65 years (both included). Clinical diagnosis of persistent asthma (according to GINA guidelines 2002) for at least 6 months prior to screening. Maintenance on a stable dose of inhaled corticosteroids over the previous 6 weeks prior to screening, either together with a short-or long-acting beta-2-agonist. Screening FEV1 value of 60 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Smoking history during the last 12 months or history of smoking more than 10 pack-yrs. Presence of clinically significant diseases other than asthma (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc), which, in the opinion of the investigator, may either put the patient at risk because of participation in the trial, or diseases which may influence the results of the study or the patient’s ability to take part in it. Presence of relevant pulmonary diseases or history of thoracic surgery, such as: • Known active tuberculosis. • History of interstitial lung or pulmonary thromboembolic disease. • Pulmonary resection during the past 12 months. • History of status asthmaticus. • History of bronchiectasis secondary to respiratory diseases (e.g., cystic fibrosis, Kartagener’s syndrome, etc). • History of chronic bronchitis, emphysema, allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration. Hospitalisation or emergency room treatment for acute asthma in the 6 weeks prior to screening, between screening and the start of the first treatment period, or between treatment periods. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit. Positive laboratory test for urine illicit drug screening. Positive test Hepatitis B surface antigen or HBc, HIV and Hepatitis C antibodies. Patients vaccinated for Hepatitis B and not infected from the disease can take part in the trial. History of severe allergy (anaphylaxis, angioneurotic oedema) or drug hypersensitivity reactions or hypersensitivity to drugs chemically related IMP. Intention to use any concomitant medication not permitted by this protocol or insufficient washout period for a particular prohibited medication (see section 10.3). Treatment with ß2-antagonists (including eye drops). Treatment with drugs that may modify QT interval (non-potassium sparing diuretics, MAOIs, TCAs, SSRIs, antipsychotic agents, serotonin receptor agonists, macrolide antibiotics, fluoroquinolone antibiotics, anti-protozoal antibiotics and antihypertensive agents). Excessive coffee, tea or chocolate consumption (more than 6 cups/day on average) or cola / caffeine containing drinks (more than 6 glasses/day). Loss of more than 400 mL of blood within the previous 3 months, or more than 250 mL within the month before entering the trial. History of drug and/or alcohol abuse during the last 2 years, that may interfere with the trial activities compliance. Treatment with any Investigational Medicinal Product (IMP) within 6 weeks prior to screening or the equivalent time to 6 half-lives of the IMP, whichever is longer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the activity of single doses of LAS100977 administered by inhalation to patients with persistent asthma. To evaluate the safety, tolerability and pharmacokinetics of single doses of LAS100977 after single administration to patients with persistent asthma ;Secondary Objective: ;Primary end point(s): Spirometry Change from pre-dose in the trough FEV1 Trough FEV1, FVC, PEF and FEF25-75 (The trough value will be the mean of the 23h and 24h FEV1, FVC, PEF and FEF25-75 values) Normalised FEV1, FVC, PEF and FEF25-75 area under the curve over the 6-hour (AUC 0-6), 12-hour (AUC 0-12), 24-hour (AUC 0-24), 36-hour (AUC 0-36) post-dosing interval. Normalised FEV1, FVC, PEF and FEF25-75 area under the curve between 12 and 24 hours (AUC 12-24) post-dosing interval. Change from pre-dose in normalised FEV1 / FVC / PEF / FEF25-75 AUC 0-6, AUC 0-12, AUC 0-24, AUC 0-36, AUC 12-24. Change from pre-dose in the trough FVC, PEF and FEF25-75. Change from pre-dose in FEV1, FVC, PEF and FEF25-75 at each time point. Peak FEV1, FVC, PEF and FEF25-75: the maximum FEV1, FVC, PEF and FEF25-75 value over the first 3 hours after the morning IMP administration. Change from pre-dose in the peak FEV1, FVC, PEF and FEF25-75 . Time to peak FEV1. Number and percentage of patients achieving the peak FEV1 at each timepoint during the 3-h period after the morning IMP administration. | — |
Countries
Germany
Outcome results
None listed