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

NCT01425814 | Completed Phase 2 Results

• 2 other identifiers: M/100977/25LBC25
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Trough 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) Trough at Day 2 was computed as the average of the two values measured at 23 and 24 hours after administration of the morning dose of investigational medicinal product on Day 1 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 and FVC were selected

  Day 2

Secondary Outcomes (13)

• Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve

  Day 1

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

  Up to Day 2

• Absolute Forced Expiratory Volume in One Second (FEV1) Values

  Up to Day 2

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

  Day 1

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

  Day 1

Study Arms (6)

Arm #2

EXPERIMENTAL

Single dose, double blind treatment period

Drug: LAS100977

Arm #3

EXPERIMENTAL

Single dose, double blind treatment period

Drug: LAS100977

Arm #4

EXPERIMENTAL

Single dose, double blind treatment period

Drug: LAS100977

Arm #5

ACTIVE COMPARATOR

Single dose, double blind treatment period

Drug: Reference

Arm #6

PLACEBO COMPARATOR

Single dose, double blind treatment period

Drug: Placebo

Arm #1

EXPERIMENTAL

Single dose, double blind treatment period

Drug: LAS100977

Interventions

LAS100977 DRUG

Dry powder inhalation,Once daily, single dose

Arm #1

Reference DRUG

Dry powder inhalation (capsule),single dose

Arm #5

Placebo DRUG

Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose

Arm #6

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-lactating females aged 40 or older.
• Patients with a clinical diagnosis of COPD, according to the GOLD guidelines and stable airway obstruction.
• Patients with a post-salbutamol FEV1 equal to or greater than 30% of the predicted value and less than 80% of the predicted value
• Post-salbutamol FEV1/FVC \< 70% at screening visit.
• Pre-dose FEV1 value of first treatment period within the range of 80-120% of the FEV1 measured at screening prior to salbutamol inhalation.
• Current, or ex-cigarette smokers (former) with a smoking history of at least 10 pack-years.
• Patients whose COPD symptoms at the time of randomisation are stable compared to the Screening visit, according to the investigator's medical judgment.

You may not qualify if:

• History or current diagnosis of asthma.
• A respiratory tract infection or COPD exacerbation in the six weeks prior to the screening visit.
• Patients who have been hospitalised for an acute COPD exacerbation in the 3 months prior to screening visit.
• Clinically significant respiratory conditions other than COPD condition.
• 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 (8)

Almirall Investigational Sites#5

Berlin, 14050, Germany

Location

Almirall Investigational Sites#2

Berlin, 14057, Germany

Location

Almirall Investigational Sites#6

Frankfurt, 60596, Germany

Location

Almirall Investigational Sites#3

Großhansdorf, 22927, Germany

Location

Almirall Investigational Sites#7

Hamburg, 20354, Germany

Location

Almirall Investigational Sites#8

Lübeck, 23552, Germany

Location

Almirall Investigational Sites#1

Mainz, 55131, Germany

Location

Almirall Investigational Sites#4

Wiesbaden, 65187, Germany

Location

Related Publications (1)

• 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.

  PMID: 27439370 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Locations

DE (8)