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

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

Official Title
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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)

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: LAS100977
* Drug: LAS100977
* Drug: LAS100977
* Drug: LAS100977
* Drug: Reference
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm #2<br>Single dose, double blind treatment period | Drug: LAS100977<br>* Dry powder inhalation,Once daily, single dose<br>|
| Experimental: Arm #3<br>Single dose, double blind treatment period | Drug: LAS100977<br>* Dry powder inhalation,Once daily, single dose<br>|
| Experimental: Arm #4<br>Single dose, double blind treatment period | Drug: LAS100977<br>* Dry powder inhalation,Once daily, single dose<br>|
| Active Comparator: Arm #5<br>Single dose, double blind treatment period | Drug: Reference<br>* Dry powder inhalation (capsule),single dose<br>|
| Placebo Comparator: Arm #6<br>Single dose, double blind treatment period | Drug: Placebo<br>* Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose<br>|
| Experimental: Arm #1<br>Single dose, double blind treatment period | Drug: LAS100977<br>* Dry powder inhalation,Once daily, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Day 1 | 
| 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 | Up to Day 2 | 
| 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 | Up to Day 2 | 
| 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 | Day 1 | 
| 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 | Day 1 | 
| 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 | Day 2 | 
| 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 | Day 1 | 
| 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 | Up to Day 2 | 
| 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 | Up to Day 2 | 
| 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 | Day 1 | 
| 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 | Day 1 | 
| 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 | Up to Day 2 | 
| 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 | Up to Day 2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD