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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Reference; Drug: Placebo; Drug: LAS100977

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425814

LBC25

M/100977/25

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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87 participants in 6 patient groups, including a placebo group

Arm #2

Experimental group

Description:

Single dose, double blind treatment period

Treatment:

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Arm #3

Experimental group

Description:

Single dose, double blind treatment period

Treatment:

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Arm #4

Experimental group

Description:

Single dose, double blind treatment period

Treatment:

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Arm #5

Active Comparator group

Description:

Single dose, double blind treatment period

Treatment:

Drug: Reference

Arm #6

Placebo Comparator group

Description:

Single dose, double blind treatment period

Treatment:

Drug: Placebo

Arm #1

Experimental group

Description:

Single dose, double blind treatment period

Treatment:

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977

Drug: LAS100977