The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
LaCrossE
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)
1 other identifier
interventional
25
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 chronic-obstructive-pulmonary-disease
Started Jun 2009
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 13, 2009
CompletedFirst Posted
Study publicly available on registry
July 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
August 5, 2011
CompletedAugust 5, 2011
July 1, 2011
5 months
July 13, 2009
July 8, 2011
July 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
Maximum FEV1 value
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
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose
Trough FEV1 value
22 h, 24 h, 26 h
Secondary Outcomes (9)
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
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
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose
0, 30 min, 2 h, 4 h
- +4 more secondary outcomes
Study Arms (5)
AZD9164 100 mcg First, then Placebo for Spririva
EXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 400 mcg First, then Placebo for Spiriva
EXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
AZD9164 1200 mcg First, then Placebo for Spiriva
EXPERIMENTAL1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
Spiriva 18 mcg First, then Placebo for AZD9164
ACTIVE COMPARATOR1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
Placebo for Spiriva First, then Placebo for AZD9164
PLACEBO COMPARATOR1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
Interventions
Solution for inhalation through nebulization, single dose
Dry powder for inhalation, single dose
Placebo
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of COPD
- FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC \< 70%
You may not qualify if:
- Any clinically relevant abnormal findings at screening examinations
- Any clinically significant disease or disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Gothenburg, Sweden
Research Site
Luleå, Sweden
Research Site
Lund, Sweden
Related Publications (1)
Bjermer L, Bengtsson T, Jorup C, Lotvall J. Local and systemic effects of inhaled AZD9164 compared with tiotropium in patients with COPD. Respir Med. 2013 Jan;107(1):84-90. doi: 10.1016/j.rmed.2012.09.014. Epub 2012 Oct 23.
PMID: 23098686DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Leif Bjermer, Prof, MD, PhD
University Hospital in Lund, Sweden
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2009
First Posted
July 14, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
August 5, 2011
Results First Posted
August 5, 2011
Record last verified: 2011-07