Asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Almirall S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male and non-pregnant, non-lactating female patients aged 18-70 years (both included). 2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update)(2) for at least 6 months prior to screening. 4. Screening FEV1 value of 60% =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years. 2. Patients diagnosed with COPD. 3. Patients diagnosed with asthma where the diagnostic was done in the elderly (>65 years old). 4. 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. 5. Difficult-to-treat asthma (requiring frequent Oral corticosteroids or steroid bursts, Xolair® use, or use of immunomodulators). 6. Presence of relevant pulmonary diseases or history of thoracic surgery. 7. Hospitalisation or emergency room treatment for acute asthma in the 3 months prior to screening. 8. Recent Respiratory tract infections within 6 weeks before Screening Visit. Patients who develop a respiratory tract infection or exacerbation during the run-in period will be discontinued from the trial prior to randomisation. 9. 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. 12. History of severe allergy (anaphylaxis, angioneurotic oedema) or drug hypersensitivity reactions or hypersensitivity to drugs chemically related IMP (including report of paradoxical bronchospasm). 14. Treatment with ß2-antagonists (including eye drops). 16. Patients unable to properly use a dry powder or pMDI inhaler device. 19. Treatment with any Investigational Medicinal Product (IMP) within 4 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 evaluate the pharmacodynamics of single doses of inhaled LAS100977 0.313, 0.625, 1.25 and 2.5 µg QD in patients with persistent asthma. • To assess the safety and tolerability of the fore-mentioned LAS100977 doses in the same target population.;Secondary Objective: ;Primary end point(s): Change from baseline to peak FEV1 at Day 1;Timepoint(s) of evaluation of this end point: Please refer to E.5.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline to (trough) FEV1 and FVC on Day 2. 2. Change from baseline in the FEV1 and FVC at each specific time-point on Day 1 and Day 2. 3.Percentage of patients with an increase from baseline to peak FEV1 >=12% and >= 200 mL on Day 1. 4. Change from baseline in normalised FEV1 and FVC AUC0-6 on Day 1, AUC0-12 on Day 1 and AUC 0-24 on Day 1 and Day 2. ;Timepoint(s) of evaluation of this end point: Please refer to E 5.2 | — |
Countries
United Kingdom
Contacts
Public ContactAnna Ribera -Clinical Trial Manager
Almirall S.A.
Outcome results
None listed