Clinical trial NCT01425801: Single Dose Study to Assess Efficacy, Safety and Tolerability of LAS100977 in Asthmatic Patients.
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 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
Secondary outcomes:
measure: Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
measure: Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
measure: Time to Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
measure: Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)
timeFrame: Baseline and +23 h and +24 h post-dose
measure: Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
measure: Absolute Values of Forced Expiratory Volume (FEV1) at Each Timepoint
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
measure: Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
measure: Percentage Change From Baseline in Forced Expiratory Volume (FEV1) at Each Timepoint
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
measure: Change From Baseline in Peak Forced Vital Capacity (FVC)
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose
measure: Peak Forced Vital Capacity (FVC)
timeFrame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
measure: Time to Peak Forced Vital Capacity (FVC)
timeFrame: +15 min, +30 min, +1 h, +2 h, +3 h, +4 h
measure: Change From Baseline to Trough Forced Vital Capacity (FVC)
timeFrame: Baseline and +23 h +24 h post-dose
measure: Change From Baseline in Normalized Forced Vital Capacity (FVC) Area Under the Curve (AUC)
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h and +24 h
measure: Absolute Values of Forced Vital Capacity (FVC) at Each Timepoint
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
measure: Change From Baseline in Forced Vital Capacity (FVC) at Each Timepoint
timeFrame: Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h, +6 h, +8 h, +12 h, +14 h, +23 h, +24 h, and +36 h
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Almirall Investigational Sites#6
city: Berlin
country: Germany
facility: Almirall Investigational Sites#4
city: Berlin
country: Germany
facility: Almirall Investigational Sites#1
city: Frankfurt
country: Germany
facility: Almirall Investigational Sites#3
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Sites#2
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#8
city: Wiesbaden
country: Germany
facility: Almirall Investigational Sites#5
city: London
country: United Kingdom
facility: Almirall Investigational Sites#2
city: Manchester
country: United Kingdom
facility: Almirall Investigational Sites#1
Study officials:
affiliation: AstraZeneca
name: Carol Astbury, PhD
role: STUDY_DIRECTOR
References:
citation: Singh D, Pujol H, Ribera A, Seoane B, Massana E, Astbury C, Ruiz S, de Miquel G. A dose-ranging study of the bronchodilator effects of abediterol (LAS100977), a long-acting beta2-adrenergic agonist, in asthma; a Phase II, randomized study. BMC Pulm Med. 2014 Nov 14;14:176. doi: 10.1186/1471-2466-14-176.