Back to resultsSingle Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
LAS100977
LAS100977
LAS100977
LAS100977
Reference
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Males and non-pregnant, non-lactating females aged 40 or older.
- Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
- Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
- Post-salbutamol FEV1/FVC < 70% at screening visit.
- Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
- Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
- 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:
- History or current diagnosis of asthma.
- A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
- Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
- Clinically significant respiratory conditions other than COPD condition.
- Clinically significant cardiovascular conditions.
- Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
- Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
- 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.
Sites / Locations
- Almirall Investigational Sites#5
- Almirall Investigational Sites#2
- Almirall Investigational Sites#6
- Almirall Investigational Sites#3
- Almirall Investigational Sites#7
- Almirall Investigational Sites#8
- Almirall Investigational Sites#1
- Almirall Investigational Sites#4
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Experimental
Arm Label
Arm #2
Arm #3
Arm #4
Arm #5
Arm #6
Arm #1
Arm Description
Single dose, double blind treatment period
Single dose, double blind treatment period
Single dose, double blind treatment period
Single dose, double blind treatment period
Single dose, double blind treatment period
Single dose, double blind treatment period
Outcomes
Primary Outcome Measures
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
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
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
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 Expiratory Volume in One Second (FEV1)
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
Absolute Forced Expiratory Volume in One Second (FEV1) Values
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 Expiratory Volume in One Second (FEV1)
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)
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)
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
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
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)
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
Absolute Forced Vital Capacity (FVC) Values
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)
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)
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)
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
Absolute Inspiratory Capacity (IC) Values
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01425814
Brief Title
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
Official Title
A Phase IIa, Randomised, Single Dose, Double-blind, Double-dummy, 6 Way Complete Cross-over, Placebo Controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of 4 Strengths of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm #2
Arm Type
Experimental
Arm Description
Single dose, double blind treatment period
Arm Title
Arm #3
Arm Type
Experimental
Arm Description
Single dose, double blind treatment period
Arm Title
Arm #4
Arm Type
Experimental
Arm Description
Single dose, double blind treatment period
Arm Title
Arm #5
Arm Type
Active Comparator
Arm Description
Single dose, double blind treatment period
Arm Title
Arm #6
Arm Type
Placebo Comparator
Arm Description
Single dose, double blind treatment period
Arm Title
Arm #1
Arm Type
Experimental
Arm Description
Single dose, double blind treatment period
Intervention Type
Drug
Intervention Name(s)
LAS100977
Intervention Description
Dry powder inhalation,Once daily, single dose
Intervention Type
Drug
Intervention Name(s)
LAS100977
Intervention Description
Dry powder inhalation,Once daily, single dose
Intervention Type
Drug
Intervention Name(s)
LAS100977
Intervention Description
Dry powder inhalation,Once daily, single dose
Intervention Type
Drug
Intervention Name(s)
LAS100977
Intervention Description
Dry powder inhalation,Once daily, single dose
Intervention Type
Drug
Intervention Name(s)
Reference
Intervention Description
Dry powder inhalation (capsule),single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Primary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
Description
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
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
Description
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 Frame
Day 1
Title
Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
Description
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 Frame
Up to Day 2
Title
Absolute Forced Expiratory Volume in One Second (FEV1) Values
Description
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 Frame
Up to Day 2
Title
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
Description
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 Frame
Day 1
Title
Time to Peak Forced Expiratory Volume in One Second (FEV1)
Description
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 Frame
Day 1
Title
Change From Baseline in Trough Forced Vital Capacity (FVC)
Description
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
Time Frame
Day 2
Title
Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
Description
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 Frame
Day 1
Title
Change From Baseline in Forced Vital Capacity (FVC)
Description
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 Frame
Up to Day 2
Title
Absolute Forced Vital Capacity (FVC) Values
Description
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 Frame
Up to Day 2
Title
Change From Baseline in Peak Forced Vital Capacity (FVC)
Description
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 Frame
Day 1
Title
Time to Peak Forced Vital Capacity (FVC)
Description
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 Frame
Day 1
Title
Change From Baseline in Inspiratory Capacity (IC)
Description
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
Time Frame
Up to Day 2
Title
Absolute Inspiratory Capacity (IC) Values
Description
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
Time Frame
Up to Day 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and non-pregnant, non-lactating females aged 40 or older.
Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
Post-salbutamol FEV1/FVC < 70% at screening visit.
Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
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:
History or current diagnosis of asthma.
A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
Clinically significant respiratory conditions other than COPD condition.
Clinically significant cardiovascular conditions.
Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Astbury, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Almirall Investigational Sites#5
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Almirall Investigational Sites#2
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Almirall Investigational Sites#6
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Almirall Investigational Sites#3
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Almirall Investigational Sites#7
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Almirall Investigational Sites#8
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Almirall Investigational Sites#1
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Almirall Investigational Sites#4
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27439370
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=3969&filename=M-100977-25_CSRsynopsis.pdf
Description
CSR Synopsis
Learn more about this trial
Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
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