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

NCT01425801 | Completed Phase 2 Results

• 1 other identifier: M/100977/202
• Study Type: interventional
• Target: 62
• Locations: 2 countries
• Sites: 9

Brief Summary

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

Conditions

Asthma

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)

  Baseline was the average of the two values measured just prior to the administration of the dose of investigational medicinal product at Day 1 of each visit (time points -45 min and -15 min). The peak was computed as the highest value observed for each patient during the 4-hour period immediately after the investigational medicinal product administered in the morning. At each time point, three technically adequate lung function measurements were performed by spirometry according to the acceptability and repeatability criteria of the ATS/ERS; the highest values for the FEV1 were selected.

  Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

Secondary Outcomes (15)

• Percentage Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)

  Baseline and +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

• Peak Forced Expiratory Volume in One Second (FEV1)

  +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

• Time to Peak Forced Expiratory Volume in One Second (FEV1)

  +15 min, +30 min, +1 h, +2 h, +3 h, +4 h post-dose

• Change From Baseline to Trough Forced Expiratory Volume in One Second (FEV1)

  Baseline and +23 h and +24 h post-dose

• Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-24h at Day 1

  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

Study Arms (6)

LAS100977 0.625 μg

EXPERIMENTAL

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

Drug: LAS100977 0.625 μg; Drug: Salbutamol placebo

LAS100977 1.25 μg

EXPERIMENTAL

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

Drug: LAS100977 1.25 μg; Drug: Salbutamol placebo

LAS100977 2.5 μg

EXPERIMENTAL

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

Drug: LAS100977 2.5 μg; Drug: Salbutamol placebo

Salbutamol

ACTIVE COMPARATOR

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

Drug: Salbutamol 400 μg; Drug: LAS100977 placebo

Placebo

PLACEBO COMPARATOR

Placebo to LAS100977, and placebo to salbutamol

Drug: Salbutamol placebo; Drug: LAS100977 placebo

LAS100977 0.313 μg

EXPERIMENTAL

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

Drug: LAS100977 0.313 μg; Drug: Salbutamol placebo

Interventions

LAS100977 0.313 μg DRUG

Dry powder inhalation, once-daily, single-dose

LAS100977 0.313 μg

LAS100977 0.625 μg DRUG

Dry powder inhalation, once-daily, single-dose

LAS100977 0.625 μg

LAS100977 1.25 μg DRUG

Dry powder inhalation, once-daily, single-dose

LAS100977 1.25 μg

LAS100977 2.5 μg DRUG

Dry powder inhalation, once-daily, single-dose

LAS100977 2.5 μg

Salbutamol 400 μg DRUG

Pressurized inhalation suspension, once-daily, single-dose

Salbutamol

Salbutamol placebo DRUG

Pressurized inhalation, once-daily

LAS100977 0.313 μg; LAS100977 0.625 μg; LAS100977 1.25 μg; LAS100977 2.5 μg; Placebo

LAS100977 placebo DRUG

Dry powder inhalation, once-daily

Placebo; Salbutamol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
• Patients diagnosed with COPD.
• Recent Respiratory tract infections within 6 weeks before Screening Visit.
• 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.
• Clinically significant respiratory conditions.
• Clinically significant cardiovascular conditions.
• Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
• Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Almirall Investigational Sites#6

Berlin, 10117, Germany

Location

Almirall Investigational Sites#4

Berlin, 14050, Germany

Location

Almirall Investigational Sites#1

Berlin, 14057, Germany

Location

Almirall Investigational Sites#3

Frankfurt, 60596, Germany

Location

Almirall Investigational Sites#2

Großhansdorf, 22927, Germany

Location

Almirall Investigational Sites#8

Hamburg, 20249, Germany

Location

Almirall Investigational Sites#5

Wiesbaden, 65187, Germany

Location

Almirall Investigational Sites#2

London, W1G 8HT, United Kingdom

Location

Almirall Investigational Sites#1

Manchester, M3 9QZ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25398689 DERIVED

Related Links

• Synopsis-M-100977-202

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Study Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Carol Astbury, PhD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2011
• First Posted: August 30, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: May 8, 2018
• Results First Posted: January 26, 2018

Record last verified: 2018-04

Locations

DE (7); GB (2)