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

• ClinicalTrials.gov Identifier: NCT01425814
• Recruitment Status: Completed
• First Posted: August 30, 2011
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Sponsor: AstraZeneca
• Information provided by (Responsible Party): AstraZeneca

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: LAS100977; Drug: Reference; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: August 2011
• Actual Primary Completion Date: March 2012
• Actual Study Completion Date: March 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm #2; Single dose, double blind treatment period	Drug: LAS100977; Dry powder inhalation,Once daily, single dose
Experimental: Arm #3; Single dose, double blind treatment period	Drug: LAS100977; Dry powder inhalation,Once daily, single dose
Experimental: Arm #4; Single dose, double blind treatment period	Drug: LAS100977; Dry powder inhalation,Once daily, single dose
Active Comparator: Arm #5; Single dose, double blind treatment period	Drug: Reference; Dry powder inhalation (capsule),single dose
Placebo Comparator: Arm #6; Single dose, double blind treatment period	Drug: Placebo; Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
Experimental: Arm #1; Single dose, double blind treatment period	Drug: LAS100977; Dry powder inhalation,Once daily, single dose

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Day 2 ]
   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

Secondary Outcome Measures :

1. Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve [ Time Frame: Day 1 ]
   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) 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
2. Change From Baseline in Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Up to Day 2 ]
   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) 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
3. Absolute Forced Expiratory Volume in One Second (FEV1) Values [ Time Frame: Up to Day 2 ]
   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
4. Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Day 1 ]
   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) 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
5. Time to Peak Forced Expiratory Volume in One Second (FEV1) [ Time Frame: 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
6. Change From Baseline in Trough Forced Vital Capacity (FVC) [ Time Frame: Day 2 ]
   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
7. Change From Baseline in Normalised Forced Vital Capacity (FVC) Area Under the Curve [ Time Frame: Day 1 ]
   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) 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
8. Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Up to Day 2 ]
   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) 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
9. Absolute Forced Vital Capacity (FVC) Values [ Time Frame: Up to Day 2 ]
   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
10. Change From Baseline in Peak Forced Vital Capacity (FVC) [ Time Frame: Day 1 ]
    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) 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
11. Time to Peak Forced Vital Capacity (FVC) [ Time Frame: 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
12. Change From Baseline in Inspiratory Capacity (IC) [ Time Frame: Up to Day 2 ]
    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) 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
13. Absolute Inspiratory Capacity (IC) Values [ Time Frame: Up to Day 2 ]
    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

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Germany

Almirall Investigational Sites#5

Berlin, Germany, 14050

Almirall Investigational Sites#2

Berlin, Germany, 14057

Almirall Investigational Sites#6

Frankfurt, Germany, 60596

Almirall Investigational Sites#3

Grosshansdorf, Germany, 22927

Almirall Investigational Sites#7

Hamburg, Germany, 20354

Almirall Investigational Sites#8

Lübeck, Germany, 23552

Almirall Investigational Sites#1

Mainz, Germany, 55131

Almirall Investigational Sites#4

Wiesbaden, Germany, 65187

Sponsors and Collaborators

AstraZeneca

Investigators

• Study Director: Carol Astbury, PhD; AstraZeneca

More Information

Additional Information:

CSR Synopsis 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Beier J, Pujol H, Seoane B, Jimenez E, Astbury C, Massana E, Ruiz S, de Miquel G. Abediterol, a novel long-acting β2-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.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT01425814
• Other Study ID Numbers: M/100977/25; LBC25
• First Posted: August 30, 2011
• Results First Posted: April 10, 2017
• Last Update Posted: April 10, 2017
• Last Verified: February 2017

Keywords provided by AstraZeneca:

COPD

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases