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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
Almirall, S.A.
ClinicalTrials.gov Identifier:
NCT01425801
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 of single doses of inhaled LAS100977 QD in patients with persistent asthma.


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 Doses of LAS100977 QD Compared to Placebo and an Active Comparator in Patients With Persistent Asthma.

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 36 hours


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: From Visit 1 to Follow up Visit ] [ Designated as safety issue: Yes ]
    Adverse events: patients will be instructed to spontaneously report any untoward medical occurrence during the clinical trial.


Enrollment: 54
Study Start Date: August 2011
Study Completion Date: February 2012
Primary Completion Date: February 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
Pressurized inhalation suspension, Once daily , single dose
Placebo Comparator: Arm #6
Single dose, double blind treatment period
Drug: Placebo
Dry powder inhalation or Pressurized inhalation
Experimental: Arm #1
Single dose, double blind treatment period
Drug: LAS100977
Dry powder inhalation,Once daily, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Current smokers, former smokers within the last 6 months, or ex-smokers with a history of more than 10 pack-years.
  2. Patients diagnosed with COPD.
  3. Recent Respiratory tract infections within 6 weeks before Screening Visit.
  4. 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.
  5. Clinically significant respiratory conditions.
  6. Clinically significant cardiovascular conditions.
  7. Patients unable to properly use a dry powder or pMDI inhaler device or unable to perform acceptable spirometry.
  8. Clinically relevant abnormalities laboratory, ECG parameters or physical examination results at the screening evaluation that in the investigator's opinion, preclude study participation.
  9. 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: NCT01425801

Locations
Germany
Almirall Investigational Sites#1
Berlin, Germany, 14057
Almirall Investigational Sites#6
Berlin, Germany, 10117
Almirall Investigational Sites#4
Berlin, Germany, 14050
Almirall Investigational Sites#3
Frankfurt, Germany, 60596
Almirall Investigational Sites#2
Grosshansdorf, Germany, 22927
Almirall Investigational Sites#8
Hamburg, Germany, 20249
Almirall Investigational Sites#5
Wiesbaden, Germany, 65187
United Kingdom
Almirall Investigational Sites#2
London, United Kingdom, W1G 8HT
Almirall Investigational Sites#1
Manchester, United Kingdom, M3 9QZ
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: NCT01425801     History of Changes
Other Study ID Numbers: M/100977/202
Study First Received: August 29, 2011
Last Updated: March 6, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Almirall, S.A.:
COPD

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

ClinicalTrials.gov processed this record on August 20, 2014