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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01425814
First received: August 29, 2011
Last updated: March 6, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: LAS100977
Drug: Reference
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Almirall, S.A.:

Primary Outcome Measures:
  • Forced Expiratory Volume in first second (FEV1) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Forced Expiratory Volume in first second (FEV1) will be determined at pre-dose untill 36hours


Secondary Outcome Measures:
  • Forced Vital Capacity (FVC) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Forced Vital Capacity (FVC) will be the parameters determined at pre-dose till 36 hours

  • Adverse events evaluation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Adverse events: patients will be instructed to spontaneously report any untoward medical occurrence during the clinical trial, from the signature of the informed consent to 30 days after last study drug administration.


Enrollment: 60
Study Start Date: August 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425814

Locations
Germany
Almirall Investigational Sites#2
Berlin, Germany, 14057
Almirall Investigational Sites#5
Berlin, Germany, 14050
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
Almirall, S.A.
Forest Laboratories
Investigators
Study Director: Estrella Garcia, PhD Almirall Global Clinical Operations & SR
  More Information

No publications provided

Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT01425814     History of Changes
Other Study ID Numbers: M/100977/25, LBC25
Study First Received: August 29, 2011
Last Updated: March 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Almirall, S.A.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014