Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
NCT ID: NCT01425801
Last Updated: 2018-05-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2011-08-01
2012-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
NCT02479412
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
NCT01197794
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of AZD9898
NCT03140072
Repeat Dose Safety Study for Compound to Treat Asthma
NCT01202214
Efficacy and Safety of Inhaled AZD1402 Administered for Four Weeks in Adults With Asthma on Medium-to-High Dose Inhaled Corticosteroids
NCT04643158
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LAS100977 0.625 μg
Single-dose LAS100977 0.625 μg, during double-blind treatment period
LAS100977 0.625 μg
Dry powder inhalation, once-daily, single-dose
Salbutamol placebo
Pressurized inhalation, once-daily
LAS100977 1.25 μg
Single-dose LAS100977 1.25 μg, during double-blind treatment period
LAS100977 1.25 μg
Dry powder inhalation, once-daily, single-dose
Salbutamol placebo
Pressurized inhalation, once-daily
LAS100977 2.5 μg
Single-dose LAS100977 2.5 μg, during double-blind treatment period
LAS100977 2.5 μg
Dry powder inhalation, once-daily, single-dose
Salbutamol placebo
Pressurized inhalation, once-daily
Salbutamol
Single-dose salbutamol 400 μg, during double-blind treatment period
Salbutamol 400 μg
Pressurized inhalation suspension, once-daily, single-dose
LAS100977 placebo
Dry powder inhalation, once-daily
Placebo
Placebo to LAS100977, and placebo to salbutamol
Salbutamol placebo
Pressurized inhalation, once-daily
LAS100977 placebo
Dry powder inhalation, once-daily
LAS100977 0.313 μg
Single-dose LAS100977 0.313 μg, during double-blind treatment period
LAS100977 0.313 μg
Dry powder inhalation, once-daily, single-dose
Salbutamol placebo
Pressurized inhalation, once-daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LAS100977 0.313 μg
Dry powder inhalation, once-daily, single-dose
LAS100977 0.625 μg
Dry powder inhalation, once-daily, single-dose
LAS100977 1.25 μg
Dry powder inhalation, once-daily, single-dose
LAS100977 2.5 μg
Dry powder inhalation, once-daily, single-dose
Salbutamol 400 μg
Pressurized inhalation suspension, once-daily, single-dose
Salbutamol placebo
Pressurized inhalation, once-daily
LAS100977 placebo
Dry powder inhalation, once-daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
3. Screening FEV1 value of 60% \< FEV1 ≤ 85% of the predicted normal value.
4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
6. Patients on a stable dose and regimen
Exclusion Criteria
2. Patients diagnosed with COPD.
3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
4. 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.
5. Clinically significant respiratory conditions.
6. Clinically significant cardiovascular conditions.
7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
9. Patients who intend to use any concomitant medication not permitted by this protocol or who have not undergone the required washout period for a particular prohibited medication.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carol Astbury, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Almirall Investigational Sites#6
Berlin, , Germany
Almirall Investigational Sites#4
Berlin, , Germany
Almirall Investigational Sites#1
Berlin, , Germany
Almirall Investigational Sites#3
Frankfurt, , Germany
Almirall Investigational Sites#2
Großhansdorf, , Germany
Almirall Investigational Sites#8
Hamburg, , Germany
Almirall Investigational Sites#5
Wiesbaden, , Germany
Almirall Investigational Sites#2
London, , United Kingdom
Almirall Investigational Sites#1
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G. A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study. BMC Pulm Med. 2014 Nov 14;14:176. doi: 10.1186/1471-2466-14-176.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
M/100977/202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.