Skip to main content
OpenTrials
Completed

NCT Number: NCT01425814

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Almirall Investigational Sites#2, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LAS100977

Drug

Dry powder inhalation,Once daily, single dose

reference

Drug

Dry powder inhalation (capsule),single dose

Placebo

Drug

Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 30, 2011
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.