Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: LAS100977; Drug: Placebo; Drug: Reference

• Registration Number: NCT01425814
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-29
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2017-01-03
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-27
• Last Update Submitted: 2017-02-27
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

1. Males and non-pregnant, non-lactating females aged 40 or older.
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

1. History or current diagnosis of asthma.
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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm #2	LAS100977	Single dose, double blind treatment period
Arm #4	LAS100977	Single dose, double blind treatment period
Arm #6	Placebo	Single dose, double blind treatment period
Arm #1	LAS100977	Single dose, double blind treatment period
Arm #3	LAS100977	Single dose, double blind treatment period
Arm #5	Reference	Single dose, double blind treatment period

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)	Day 2	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)	Day 1	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Time to Peak Forced Expiratory Volume in One Second (FEV1)	Day 1	At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Absolute Inspiratory Capacity (IC) Values	Up to Day 2	At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)	Up to Day 2	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve	Day 1	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Change From Baseline in Inspiratory Capacity (IC)	Up to Day 2	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve	Day 1	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Change From Baseline in Forced Vital Capacity (FVC)	Up to Day 2	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Change From Baseline in Peak Forced Vital Capacity (FVC)	Day 1	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Time to Peak Forced Vital Capacity (FVC)	Day 1	At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Absolute Forced Expiratory Volume in One Second (FEV1) Values	Up to Day 2	At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Absolute Forced Vital Capacity (FVC) Values	Up to Day 2	At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected
Change From Baseline in Trough Forced Vital Capacity (FVC)	Day 2	Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 and FVC were selected

Trial Locations

Locations (8)

Almirall Investigational Sites#6; 🇩🇪 Frankfurt, Germany

Almirall Investigational Sites#3; 🇩🇪 Grosshansdorf, Germany

Almirall Investigational Sites#8; 🇩🇪 Lübeck, Germany

Almirall Investigational Sites#5; 🇩🇪 Berlin, Germany

Almirall Investigational Sites#4; 🇩🇪 Wiesbaden, Germany

Almirall Investigational Sites#2; 🇩🇪 Berlin, Germany

Almirall Investigational Sites#1; 🇩🇪 Mainz, Germany

Almirall Investigational Sites#7; 🇩🇪 Hamburg, Germany