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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425814
• Other study ID #: M/100977/25
• Secondary ID: LBC25
• Status: Completed
• Phase: Phase 2
• First received: August 29, 2011
• Last updated: October 3, 2016
• Start date: August 2011
• Est. completion date: March 2012

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• LAS100977
Dry powder inhalation,Once daily, single dose
• LAS100977
Dry powder inhalation,Once daily, single dose
• LAS100977
Dry powder inhalation,Once daily, single dose
• LAS100977
Dry powder inhalation,Once daily, single dose
• Reference
Dry powder inhalation (capsule),single dose
• Placebo
Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose

Locations

Country	Name	City	State
Germany	Almirall Investigational Sites#2	Berlin
Germany	Almirall Investigational Sites#5	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in first second (FEV1)	Forced Expiratory Volume in first second (FEV1) will be determined at pre-dose untill 36hours	24 hours	No
Secondary	Forced Vital Capacity (FVC)	Forced Vital Capacity (FVC) will be the parameters determined at pre-dose till 36 hours	24 hours	No
Secondary	Adverse events evaluation	Adverse events: patients will be instructed to spontaneously report any untoward medical occurrence during the clinical trial, from the signature of the informed consent to 30 days after last study drug administration.	30 days	Yes