Adult male subjects, aged 18 to 70 years, clinically diagnosed of persistent asthma (according to GINA guidelies 2007 update) for at least 6 months before screening, but who are otherwise in good general physical health MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Sponsors
Laboratorios Almirall, S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Adult male subjects aged 18-70 years (both included). 2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2007 update) for at least 6 months prior to screening. 3. Maintenance on a stable dose of inhaled corticosteroids together with either a short or a long-acting beta2-agonist over the previous 6 weeks prior to screening. 4. Screening FEV1 value of 60% = 85% of the predicted normal value after a washout of at least 6 hours for short-acting beta2-agonists and 72 hours for long-acting beta2-agonists, if applicable. - Predicted normal values to be used for calculation purposes are to be based on European Community for Steel and Coal predicted values (Quanjer et al. 1993). 5. FEV1 reversibility >= 12% and an absolute increase of at least 200 ml over baseline value within 30 minutes after inhalation of 400 µg (four inhalations) of salbutamol via a metered dose inhaler. 6. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation [i.e. within the interval: 0.8 x pre-salbutamol FEV1 (screening) – 1.2 x pre-salbutamol FEV1 (screening)]. 7. Normal values or non-clinically relevant abnormalities in the results of the physical examination and laboratory tests at screening, as judged by the medical investigator. 8. Normal values or abnormalities not clinically relevant in the screening 12-lead ECG, as judged by a cardiologist. QT and QTc [calculated according to Bazett’s formulae (QTc=QT [msec] / RR [sec]] lower than 500 milliseconds and lower than or equal to 450 milliseconds, respectively, in the ECGs performed at screening and before the first IMP administration. 9. Ability to communicate adequately with the investigator and comply with the protocol requirements, instructions and protocol-stated restrictions. 10. Ability to use an inhaler device and perform spirometries. 11. Eligibility and ability to participate in the trial and consent to do so in writing after the purpose and nature of the investigation have been explained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Smoking history during the last 12 months or history of smoking more than 10 pack-years. 2. 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. 3. 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. 4. 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. 5. 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. 6. History of severe allergy (anaphylaxis, angioneurotic oedema) or drug hypersensitivity reactions or hypersensitivity to drugs chemically related IMP. 7. Intention to use any concomitant medication not permitted by this protocol or insufficient washout period for a particular prohibited medication (see section 10.3). 8. Treatment with ß2-antagonists (including eye drops). 9. 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). 10. 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. 11. History of drug and/or alcohol abuse during the last 2 years, that may interfere with the trial activities compliance. 12. 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. 13. Vulnerable subjects (e.g. persons kept in detention) 14. Likelihood of not being co-operative, not taking the medication, not completing the Paper Diary Cards or not attending the clinic at the required times.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: a) To assess the efficacy of three doses of LAS100977 administered once daily over 7 days by inhalation to patients with stable persistent asthma. b) To evaluate the safety and tolerability of three doses of LAS100977 after 7 days administration to patients with stable persistent asthma. c) To assess explorative pharmacokinetics of three doses of LAS100977 administered once daily over 7 days by inhalation to patients with stable persistent asthma. ;Secondary Objective: ;Primary end point(s): The primary variable is the change from pre-dose in trough FEV1 at Day 7. Trough FEV1 is defined as the mean FEV1 value of the two greatest FEV1 readings measured at 23 and 24 hours after the IMP administration. | — |
Countries
Germany
Outcome results
None listed