The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease (LaCrossE)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00939211
First received: July 13, 2009
Last updated: July 8, 2011
Last verified: July 2011
  Purpose

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: AZD9164
Drug: Tiotropium
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Double-dummy, Placebo-controlled, Randomised, Multi-centre, 5-way Cross-over, Single-dose Study to Investigate the Local and Systemic Effects of Inhaled AZD9164 Compared to Tiotropium in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose [ Time Frame: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h ] [ Designated as safety issue: No ]
    Maximum FEV1 value

  • Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose [ Time Frame: 22 h, 24 h, 26 h ] [ Designated as safety issue: No ]
    Trough FEV1 value


Secondary Outcome Measures:
  • Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose [ Time Frame: 0, 15 min, 30 min, 60 min, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h ] [ Designated as safety issue: No ]
    Average FEV1 value

  • Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose [ Time Frame: 15 min ] [ Designated as safety issue: No ]
    15 min FEV1 value

  • Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average systolic blood pressure value

  • Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average diastolic blood pressure value

  • Pulse, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average pulse value

  • Heart Rate, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average heart rate value

  • QTcF, Average Effect Over 0 - 4 Hours Post-dose [ Time Frame: 0, 30 min, 2 h, 4 h ] [ Designated as safety issue: No ]
    Average QTcF value

  • Plasma AZD9164 Cmax [ Time Frame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h ] [ Designated as safety issue: No ]
    Maximum plasma concentration of AZD9164

  • Plasma AZD9164 AUC0-24 [ Time Frame: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h ] [ Designated as safety issue: No ]
    Area under the AZD9164 plasma concentration curve


Enrollment: 25
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD9164 100 mcg First, then Placebo for Spririva
1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Drug: AZD9164
Solution for inhalation through nebulization, single dose
Drug: Placebo
Placebo
Experimental: AZD9164 400 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Drug: AZD9164
Solution for inhalation through nebulization, single dose
Drug: Placebo
Placebo
Experimental: AZD9164 1200 mcg First, then Placebo for Spiriva
1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Drug: AZD9164
Solution for inhalation through nebulization, single dose
Drug: Placebo
Placebo
Active Comparator: Spiriva 18 mcg First, then Placebo for AZD9164
1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Drug: Tiotropium
Dry powder for inhalation, single dose
Other Name: Spiriva
Drug: Placebo
Placebo
Placebo Comparator: Placebo for Spiriva First, then Placebo for AZD9164
1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of COPD
  • FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%

Exclusion Criteria:

  • Any clinically relevant abnormal findings at screening examinations
  • Any clinically significant disease or disorder
  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: NCT00939211

Locations
Sweden
Research Site
Gothenburg, Sweden
Research Site
Lulea, Sweden
Research Site
Lund, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Leif Bjermer, Prof, MD, PhD University Hospital in Lund, Sweden
  More Information

No publications provided

Responsible Party: Carin Jorup, MD/MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00939211     History of Changes
Other Study ID Numbers: D1882C00003
Study First Received: July 13, 2009
Results First Received: July 8, 2011
Last Updated: July 8, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Chronic Obstructive Pulmonary Disease (COPD)
efficacy
safety
inhalation
long-acting muscarinic receptor antagonist (LAMA)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Tiotropium
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014