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

COMPLETEDPHASE2

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

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)

NCT01425814•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (8)

Almirall Investigational Sites#5

Berlin, Germany

Almirall Investigational Sites#2

Berlin, Germany

Almirall Investigational Sites#6

Frankfurt, Germany

Almirall Investigational Sites#3

Großhansdorf, Germany

Almirall Investigational Sites#7

Hamburg, Germany

Almirall Investigational Sites#8

Lübeck, Germany

Almirall Investigational Sites#1

Mainz, Germany

Almirall Investigational Sites#4

Wiesbaden, Germany

Key Dates

Start Date

August 1, 2011

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

April 10, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

LAS100977

DRUG

LAS100977

DRUG

LAS100977

DRUG

LAS100977

DRUG

Reference

DRUG

Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

View study

RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A