Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT00703391
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing AZD9668 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Germany.
Trial summary
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AZD9668
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Sep 2008
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild to moderate COPD
- Smokers or ex-smokers
- post-menopausal females
Who cannot join
- Past history or current evidence of clinically significant heart disease
- Lung disease other than COPD
- Treatment with systemic steroids within 8 weeks of study visit 2
- Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 2-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
- Being tested
- AZD9668, Placebo
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, tolerability, placebo-controlled, pharmacokinetics, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchiolitis Obliterans Syndrome, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD9668Drug
30mg oral tablets twice daily (bid) for 14 days
PlaceboDrug
Matched placebo to 30mg oral tablet twice daily (bid) for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active Treatment Receives: Drug: AZD9668 |
| 2 | Placebo comparator | Placebo Treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine Aminotransferase (ALT)
ALT level greater than 3 times the upper limit of normal
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Aspartate Aminotransferase (AST)
AST level greater than 3 times the upper limit of normal
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatine Kinase (CK)
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Total Bilirubin
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatinine
Creatinine level greater than the upper limit of normal
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Haemoglobin (Hb)
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Reticulocytes
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Leucocytes
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
QTcF interval greater than 450 ms
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF
QTcF change from baseline greater than 60 ms
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
FEV1 (Forced Expiratory Volume in the First Second)
Change from baseline to Day 14
Measured: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
AUC(0-12) following 14 days' dosing
Measured: Pre-dose on day -1 to day 15 (end of dosing)
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
Cmax following 14 days' dosing
Measured: Pre-dose on day -1 to day 15 (end of dosing)
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
tmax following 14 days' dosing
Measured: Pre-dose on day -1 to day 15 (end of dosing)
Terminal Half-life of Drug in Plasma (t1/2)
t1/2 following 14 days' dosing
Measured: Pre-dose on day -1 to day 15 (end of dosing)
Renal Clearance of Drug From Plasma (CLR)
CLR following 14 days' dosing
Measured: Pre-dose on day -1 to day 15 (end of dosing)
Secondary outcomes (4)
Sputum Absolute Neutrophil Count
Change from baseline to Day 14 in absolute neutrophil count
Measured: Pre-dose day -1 to post-dose on day 14
Sputum Differential Neutrophil Count
Change from baseline to Day 14 in percentage neutrophil count
Measured: Pre-dose day -1 to post-dose on day 14
AZD9668 Sputum Concentrations
Measured: Pre-dose day -1 to post-dose on day 14
Quantitative Sputum Bacteriology
Number of patients with an increase in bacteriological count from Day -1 to Day 15
Measured: Pre-dose day -1 to post-dose on day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionSep 2008
- Study completionSep 2008
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.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristina Panke, Principal investigator, Parexel International GmbhH (CRO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703391
- Sponsor's protocol ID
- D0520C00002
- Status last verified
- Jan 2012
- First submitted
- 19 Jun 2008
- Last updated
- 26 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2-week, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Tolerability and Pharmacokinetics of Orally Administered AZD9668 in Patients With COPD
- ClinicalTrials.gov ID
- NCT00703391
- Acronym / sponsor ID
- D0520C00002
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, tolerability, placebo-controlled, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Posted 29 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD9668Active Treatment |
| 2 | Placebo comparator | Drug: PlaceboPlacebo Treatment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mild to moderate COPD
- Smokers or ex-smokers
- post-menopausal females
Key exclusion criteria (4 listed)
- Past history or current evidence of clinically significant heart disease
- Lung disease other than COPD
- Treatment with systemic steroids within 8 weeks of study visit 2
- Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
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 |
|---|---|---|
| AZD966830mg oral tablets twice daily (bid) for 14 days | Drug | 1 |
| PlaceboMatched placebo to 30mg oral tablet twice daily (bid) for 14 days | Drug | 2 |
Primary outcome
Alanine Aminotransferase (ALT)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
ALT level greater than 3 times the upper limit of normal
Aspartate Aminotransferase (AST)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
AST level greater than 3 times the upper limit of normal
Creatine Kinase (CK)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Total Bilirubin
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Creatinine
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Creatinine level greater than the upper limit of normal
Haemoglobin (Hb)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Reticulocytes
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Leucocytes
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
QTcF (QT Interval Corrected for Heart Rate by Fridericia's Method)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF interval greater than 450 ms
QTcF
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
QTcF change from baseline greater than 60 ms
FEV1 (Forced Expiratory Volume in the First Second)
Time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)
Change from baseline to Day 14
Area Under the Plasma Concentration-time Curve From Time Zero to 12 Hours Post-dose (AUC(0-12))
Time frame: Pre-dose on day -1 to day 15 (end of dosing)
AUC(0-12) following 14 days' dosing
Observed Peak or Maximum Plasma Concentration Following Drug Administration (Cmax)
Time frame: Pre-dose on day -1 to day 15 (end of dosing)
Cmax following 14 days' dosing
Time to Reach Observed Peak or Maximum Concentration Following Oral Drug Administration (Tmax)
Time frame: Pre-dose on day -1 to day 15 (end of dosing)
tmax following 14 days' dosing
Terminal Half-life of Drug in Plasma (t1/2)
Time frame: Pre-dose on day -1 to day 15 (end of dosing)
t1/2 following 14 days' dosing
Renal Clearance of Drug From Plasma (CLR)
Time frame: Pre-dose on day -1 to day 15 (end of dosing)
CLR following 14 days' dosing
4 secondary outcomes
Sputum Absolute Neutrophil Count
Time frame: Pre-dose day -1 to post-dose on day 14
Sputum Differential Neutrophil Count
Time frame: Pre-dose day -1 to post-dose on day 14
AZD9668 Sputum Concentrations
Time frame: Pre-dose day -1 to post-dose on day 14
Quantitative Sputum Bacteriology
Time frame: Pre-dose day -1 to post-dose on day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kristina Panke principal investigator
Parexel International GmbhH (CRO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD9668 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 1 site in Germany.
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 3 inclusion and 4 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 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 29 Dec 2010). 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?
Alanine Aminotransferase (ALT) (time frame: Throughout the duration of the study (pre-dose, cmax, steady state, end of dosing and post dose)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2012.