Clinical trial NCT01425814: Single Dose Study to Assess Efficacy and Safety of 4 Doses of LAS100977 in Chronic Obstructive Pulmonary Disease (COPD) Population
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-08-30
Enrollment: 87
Sex: ALL
Minimum age (years): 40
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 (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1)
timeFrame: Day 2
Secondary outcomes:
measure: Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve
timeFrame: Day 1
measure: Change From Baseline in Forced Expiratory Volume in One Second (FEV1)
timeFrame: Up to Day 2
measure: Absolute Forced Expiratory Volume in One Second (FEV1) Values
timeFrame: Up to Day 2
measure: Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Day 1
measure: Time to Peak Forced Expiratory Volume in One Second (FEV1)
timeFrame: Day 1
measure: Change From Baseline in Trough Forced Vital Capacity (FVC)
timeFrame: Day 2
measure: Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve
timeFrame: Day 1
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Up to Day 2
measure: Absolute Forced Vital Capacity (FVC) Values
timeFrame: Up to Day 2
measure: Change From Baseline in Peak Forced Vital Capacity (FVC)
timeFrame: Day 1
measure: Time to Peak Forced Vital Capacity (FVC)
timeFrame: Day 1
measure: Change From Baseline in Inspiratory Capacity (IC)
timeFrame: Up to Day 2
measure: Absolute Inspiratory Capacity (IC) Values
timeFrame: Up to Day 2
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Almirall Investigational Sites#5
city: Berlin
country: Germany
facility: Almirall Investigational Sites#2
city: Frankfurt
country: Germany
facility: Almirall Investigational Sites#6
city: Grosshansdorf
country: Germany
facility: Almirall Investigational Sites#3
city: Hamburg
country: Germany
facility: Almirall Investigational Sites#7
city: Lübeck
country: Germany
facility: Almirall Investigational Sites#8
city: Mainz
country: Germany
facility: Almirall Investigational Sites#1
city: Wiesbaden
country: Germany
facility: Almirall Investigational Sites#4
Study officials:
affiliation: AstraZeneca
name: Carol Astbury, PhD
role: STUDY_DIRECTOR
References:
citation: Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting beta2-agonist: bronchodilation, safety, tolerability and pharmacokinetic results from a single-dose, dose-ranging, active-comparator study in patients with COPD. BMC Pulm Med. 2016 Jul 20;16(1):102. doi: 10.1186/s12890-016-0266-5.