Chronic Obstructive Pulmonary DiseasePhase 2LaCrossENCT00939211
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing AZD9164 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- AZD9164 and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 3 sitesSweden
- Study dates
- Jun 2009to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A clinical diagnosis of COPD
- FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%
Who cannot join
- Any clinically relevant abnormal findings at screening examinations
- Any clinically significant disease or disorder
Trial locations and contacts
3 sites in 1 country.
About this study
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)
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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- AZD9164, Tiotropium, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), efficacy, safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9164Drug
Solution for inhalation through nebulization, single dose
TiotropiumDrug
Also called Spiriva
Dry powder for inhalation, single dose
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD9164 100 mcg First, then Placebo for Spririva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation Receives: Drug: AZD9164; Drug: Placebo |
| AZD9164 400 mcg First, then Placebo for Spiriva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation Receives: Drug: AZD9164; Drug: Placebo |
| AZD9164 1200 mcg First, then Placebo for Spiriva | Experimental | 1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation Receives: Drug: AZD9164; Drug: Placebo |
| Spiriva 18 mcg First, then Placebo for AZD9164 | Active comparator | 1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) Receives: Drug: Tiotropium; Drug: Placebo |
| Placebo for Spiriva First, then Placebo for AZD9164 | Placebo comparator | 1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
Maximum FEV1 value
Measured: 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
Measured: 22 h, 24 h, 26 h
Secondary outcomes (9)
Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose
Average FEV1 value
Measured: 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 FEV1 value
Measured: 15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Average systolic blood pressure value
Measured: 0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Average diastolic blood pressure value
Measured: 0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose
Average pulse value
Measured: 0, 30 min, 2 h, 4 h
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
Average heart rate value
Measured: 0, 30 min, 2 h, 4 h
QTcF, Average Effect Over 0 - 4 Hours Post-dose
Average QTcF value
Measured: 0, 30 min, 2 h, 4 h
Plasma AZD9164 Cmax
Maximum plasma concentration of AZD9164
Measured: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD9164 AUC0-24
Area under the AZD9164 plasma concentration curve
Measured: 0, 5 min, 15 min, 30 min, 60 min, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Leif Bjermer, Prof, MD, PhD, Principal investigator, University Hospital in Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939211
- Sponsor's protocol ID
- D1882C00003
- Acronym
- LaCrossE
- Status last verified
- Jul 2011
- First submitted
- 13 Jul 2009
- Last updated
- 5 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23098686
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00939211
- Acronym / sponsor ID
- LaCrossE / D1882C00003
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), efficacy, safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 14 Jul 2009 (estimated)
- Results
- Posted 5 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AZD9164 100 mcg First, then Placebo for Spririva | Experimental | Drug: AZD9164, Drug: Placebo1 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 | Experimental | Drug: AZD9164, Drug: Placebo1 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 | Experimental | Drug: AZD9164, Drug: Placebo1 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 comparator | Drug: Tiotropium, Drug: Placebo1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride) |
| Placebo for Spiriva First, then Placebo for AZD9164 | Placebo comparator | Drug: Placebo1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A clinical diagnosis of COPD
- FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%
Key exclusion criteria (2 listed)
- Any clinically relevant abnormal findings at screening examinations
- Any clinically significant disease or disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD9164Solution for inhalation through nebulization, single dose | Drug | AZD9164 100 mcg First, then Placebo for Spririva, AZD9164 1200 mcg First, then Placebo for Spiriva, AZD9164 400 mcg First, then Placebo for Spiriva |
| TiotropiumAlso: SpirivaDry powder for inhalation, single dose | Drug | Spiriva 18 mcg First, then Placebo for AZD9164 |
| PlaceboPlacebo | Drug | AZD9164 100 mcg First, then Placebo for Spririva, AZD9164 1200 mcg First, then Placebo for Spiriva, AZD9164 400 mcg First, then Placebo for Spiriva, Placebo for Spiriva First, then Placebo for AZD9164, Spiriva 18 mcg First, then Placebo for AZD9164 |
Primary outcome
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
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
Trough FEV1 value
9 secondary outcomes
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
Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose
Time frame: 15 min
Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Time frame: 0, 30 min, 2 h, 4 h
Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose
Time frame: 0, 30 min, 2 h, 4 h
Pulse, Average Effect Over 0 - 4 Hours Post-dose
Time frame: 0, 30 min, 2 h, 4 h
Heart Rate, Average Effect Over 0 - 4 Hours Post-dose
Time frame: 0, 30 min, 2 h, 4 h
QTcF, Average Effect Over 0 - 4 Hours Post-dose
Time frame: 0, 30 min, 2 h, 4 h
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23098686Bjermer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leif Bjermer, Prof, MD, PhD principal investigator
University Hospital in Lund, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD9164 and Tiotropium in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00939211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2011.