Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: LAS100977 0.313 μg; Drug: LAS100977 1.25 μg; Drug: Salbutamol placebo; Drug: LAS100977 2.5 μg; Drug: LAS100977 0.625 μg; Drug: LAS100977 placebo; Drug: Salbutamol 400 μg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425801

M/100977/202

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacodynamics of single doses of inhaled LAS100977 QD in patients with persistent asthma.

Enrollment: 62 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult male and female patients aged 18-70 years (both included).
2. Clinical diagnosis of persistent asthma (according to GINA guidelines 2009 update) for at least 6 months prior to screening.
3. Screening FEV1 value of 60% < FEV1 ≤ 85% of the predicted normal value.
4. FEV1 reversibility ≥ 12% and an absolute increase of at least 200 ml over baseline value after inhalation of 400µg (four inhalations) of salbutamol.
5. Pre-dose FEV1 value of first treatment period within the range of ± 20% of the FEV1 measured at screening prior to salbutamol inhalation.
6. Patients on a stable dose and regimen

Exclusion criteria

1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
2. Patients diagnosed with COPD.
3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
4. Intubation (ever) or hospitalization for longer than 24 hours for the management of an asthma exacerbation within the preceding 6 weeks of the screening visit.
5. Clinically significant respiratory conditions.
6. Clinically significant cardiovascular conditions.
7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
9. 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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62 participants in 6 patient groups, including a placebo group

LAS100977 0.625 μg

Experimental group

Description:

Single-dose LAS100977 0.625 μg, during double-blind treatment period

Treatment:

Drug: LAS100977 0.625 μg

Drug: Salbutamol placebo

LAS100977 1.25 μg

Experimental group

Description:

Single-dose LAS100977 1.25 μg, during double-blind treatment period

Treatment:

Drug: LAS100977 1.25 μg

Drug: Salbutamol placebo

LAS100977 2.5 μg

Experimental group

Description:

Single-dose LAS100977 2.5 μg, during double-blind treatment period

Treatment:

Drug: LAS100977 2.5 μg

Drug: Salbutamol placebo

Salbutamol

Active Comparator group

Description:

Single-dose salbutamol 400 μg, during double-blind treatment period

Treatment:

Drug: LAS100977 placebo

Drug: Salbutamol 400 μg

Placebo

Placebo Comparator group

Description:

Placebo to LAS100977, and placebo to salbutamol

Treatment:

Drug: LAS100977 placebo

Drug: Salbutamol placebo

LAS100977 0.313 μg

Experimental group

Description:

Single-dose LAS100977 0.313 μg, during double-blind treatment period

Treatment:

Drug: LAS100977 0.313 μg

Drug: Salbutamol placebo