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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01425814
First received: August 29, 2011
Last updated: February 27, 2017
Last verified: February 2017
  Purpose
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: LAS100977
Drug: Reference
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 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:
  • Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve [ Time Frame: 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 Expiratory Volume in One Second (FEV1) [ Time Frame: 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

  • Absolute Forced Expiratory Volume in One Second (FEV1) Values [ Time Frame: 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 Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 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) [ Time Frame: 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 Trough Forced Vital Capacity (FVC) [ Time Frame: 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

  • Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve [ Time Frame: 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) [ Time Frame: 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

  • Absolute Forced Vital Capacity (FVC) Values [ Time Frame: 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 Peak Forced Vital Capacity (FVC) [ Time Frame: 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) [ Time Frame: 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 Inspiratory Capacity (IC) [ Time Frame: 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

  • Absolute Inspiratory Capacity (IC) Values [ Time Frame: 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


Enrollment: 87
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm #2
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Experimental: Arm #3
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Experimental: Arm #4
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose
Active Comparator: Arm #5
Single dose, double blind treatment period
Drug: Reference
Dry powder inhalation (capsule),single dose
Placebo Comparator: Arm #6
Single dose, double blind treatment period
Drug: Placebo
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Experimental: Arm #1
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose

  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425814

Locations
Germany
Almirall Investigational Sites#5
Berlin, Germany, 14050
Almirall Investigational Sites#2
Berlin, Germany, 14057
Almirall Investigational Sites#6
Frankfurt, Germany, 60596
Almirall Investigational Sites#3
Grosshansdorf, Germany, 22927
Almirall Investigational Sites#7
Hamburg, Germany, 20354
Almirall Investigational Sites#8
Lübeck, Germany, 23552
Almirall Investigational Sites#1
Mainz, Germany, 55131
Almirall Investigational Sites#4
Wiesbaden, Germany, 65187
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Carol Astbury, PhD AstraZeneca
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01425814     History of Changes
Other Study ID Numbers: M/100977/25
LBC25
Study First Received: August 29, 2011
Results First Received: January 3, 2017
Last Updated: February 27, 2017

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 21, 2017