Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
NCT ID: NCT01425814
Last Updated: 2017-04-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
87 participants
INTERVENTIONAL
2011-08-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Arm #2
Single dose, double blind treatment period
LAS100977
Dry powder inhalation,Once daily, single dose
Arm #3
Single dose, double blind treatment period
LAS100977
Dry powder inhalation,Once daily, single dose
Arm #4
Single dose, double blind treatment period
LAS100977
Dry powder inhalation,Once daily, single dose
Arm #5
Single dose, double blind treatment period
Reference
Dry powder inhalation (capsule),single dose
Arm #6
Single dose, double blind treatment period
Placebo
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Arm #1
Single dose, double blind treatment period
LAS100977
Dry powder inhalation,Once daily, single dose
Interventions
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LAS100977
Dry powder inhalation,Once daily, single dose
LAS100977
Dry powder inhalation,Once daily, single dose
LAS100977
Dry powder inhalation,Once daily, single dose
LAS100977
Dry powder inhalation,Once daily, single dose
Reference
Dry powder inhalation (capsule),single dose
Placebo
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Eligibility Criteria
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Inclusion Criteria
2. Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
3. Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
4. Post-salbutamol FEV1/FVC \< 70% at screening visit.
5. Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
6. Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
7. Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.
Exclusion Criteria
2. A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
3. Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
4. Clinically significant respiratory conditions other than COPD condition.
5. Clinically significant cardiovascular conditions.
6. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
7. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
8. 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.
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Carol Astbury, PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Almirall Investigational Sites#5
Berlin, , Germany
Almirall Investigational Sites#2
Berlin, , Germany
Almirall Investigational Sites#6
Frankfurt, , Germany
Almirall Investigational Sites#3
Großhansdorf, , Germany
Almirall Investigational Sites#7
Hamburg, , Germany
Almirall Investigational Sites#8
Lübeck, , Germany
Almirall Investigational Sites#1
Mainz, , Germany
Almirall Investigational Sites#4
Wiesbaden, , Germany
Countries
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References
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Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting beta2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD. BMC Pulm Med. 2016 Jul 20;16(1):102. doi: 10.1186/s12890-016-0266-5.
Related Links
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Other Identifiers
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LBC25
Identifier Type: -
Identifier Source: secondary_id
M/100977/25
Identifier Type: -
Identifier Source: org_study_id
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