Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01054170
Effect on Structural Changes in Airways, Measured by MSCT, of Twice Daily 60mg AZD9668 for 12 Weeks 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 9 sites in 5 countries.
Trial summary
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT) Read more about this study
- Who is it for?
- Ages 50 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
- 52 participants
- Where
- 9 sitesin 5 countries
- Study dates
- Jan 2010to Nov 2010
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD with symptoms over 1 year
- FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
- Ex-smokers for at least 12 months
Who cannot join
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Denmark3 sites
Research Site
Hellerup
Research Site
Hvidovre
Research Site
Odensec
About this study
Official title: A 12-week, Phase II, Double-blind, Placebo-Controlled, Randomised, Parallel-Group, Multi-Centre Study to Assess the Effect of 60mg AZD9668 Administered Orally Twice Daily on Structural Changes in the Airways by Multi-Slice Computed Tomography in Patients With Chronic Obstructive Pulmonary Disease.
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
- Being tested
- AZD9668, Placebo
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD, FEV1, St Georges Respiratory Questionnaire, Computed Tomography, MSCT
- 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
2 x 30 mg oral tablets twice daily (bid) for 12 weeks
PlaceboDrug
2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| AZD9668 | Experimental | Not described Receives: Drug: AZD9668 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Secondary outcomes (23)
5th Generation Wall Area Percentage
5th Generation Wall Area Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Air Trapping Index (ATI) on Expiratory Scans
ATI Percentage as a measure of structural changes in airways. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Inspiratory Capacity (IC)
Inspiratory Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Total Lung Capacity (TLC)
Total Lung Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Functional Residual Capacity (FRC)
Functional Residual Capacity (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Residual Volume (RV)
Residual volume (L) as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Specific Airway Conductance (SGaw)
Specific Airway Conductance as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Capacity of Carbon Monoxide as a measure of lung function. End of treatment Least Squares Mean.
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Vital Capacity (FVC)
Forced Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Vital Capacity (FVC)
Forced Vital Capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Slow Vital Capacity (SVC)
Slow Vital Capacity (L) as a measure of lung function, measured before bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Slow Vital Capacity (SVC)
Slow Vital capacity (L) as a measure of lung function, measured after bronchodilator (salbutamol) use in the clinic. End of treatment value or Last Observation Carried Forward (LOCF).
Measured: Measured after 12 weeks treatment (day 84)
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each morning.
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Peak Expiratory Flow (L/min) as a measure of lung function, measured at home by the patient each evening .
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each morning.
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Forced Expiratory Volume in 1 second (L) as a measure of lung function, measured at home by the patient each evening.
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Breathlessness, Cough and Sputum Scale, patient reported questionnaire as a measure of respiratory symptoms (reported on a 0 (best health status) to 12 (worst possible status) scale).
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
EXAcerbations of Chronic pulmonary disease Tool, patient questionnaire as a measure of respiratory symptoms (reported as units on a 0 (best health status) to 100 (worst possible status) scale).
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
St George's Respiratory Questionnaire for Chronic Obstructive Pulmonary Disease, as a measure of Quality of Life (reported on a % scale from 0 (best health status) to 100(worst possible status)).
Measured: Measured after 12 weeks treatment (day 84)
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Percentage of reliever free days in last 6 weeks on treatment.
Measured: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Exacerbations
Number of patients experiencing disease exacerbations on treatment.
Measured: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
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 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Asger Dirksen, Principal investigator, Gentofte Hospital, Department of Lung Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054170
- Sponsor's protocol ID
- D0520C00014
- Status last verified
- Aug 2012
- First submitted
- 20 Jan 2010
- Last updated
- 20 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nordenmark LH, Taylor R, Jorup C. Feasibility of Computed Tomography in a Multicenter COPD Trial: A Study of the Effect of AZD9668 on Structural Airway Changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5.
PubMed 26043724
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 12-week, Phase II, Double-blind, Placebo-Controlled, Randomised, Parallel-Group, Multi-Centre Study to Assess the Effect of 60mg AZD9668 Administered Orally Twice Daily on Structural Changes in the Airways by Multi-Slice Computed Tomography in Patients With Chronic Obstructive Pulmonary Disease.
- ClinicalTrials.gov ID
- NCT01054170
- Acronym / sponsor ID
- D0520C00014
- Keywords
- Chronic, obstructive, pulmonary, lung, respiratory disease, efficacy, placebo-controlled, COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 25 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD9668 | Experimental | Drug: AZD9668 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COPD with symptoms over 1 year
- FEV1/FVC < 70% and FEV1 >= 40 and < =70 % of predicted post-bronchodilator
- Ex-smokers for at least 12 months
Key exclusion criteria (3 listed)
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Worsening of COPD requiring hospitalisation and/or treatment with antibiotics and/or an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
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 |
|---|---|---|
| AZD96682 x 30 mg oral tablets twice daily (bid) for 12 weeks | Drug | AZD9668 |
| Placebo2 x matched placebo to oral tablet twice daily (bid) for 12 weeks | Drug | Placebo |
Primary outcome
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm)
Time frame: Measured after 12 weeks treatment (day 84)
AWT-Pi10 (mm) as a measure of structural changes in airways. End of treatment Least Squares Mean.
23 secondary outcomes
5th Generation Wall Area Percentage
Time frame: Measured after 12 weeks treatment (day 84)
Air Trapping Index (ATI) on Expiratory Scans
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Inspiratory Capacity (IC)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Total Lung Capacity (TLC)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Functional Residual Capacity (FRC)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Residual Volume (RV)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Specific Airway Conductance (SGaw)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Diffusion Capacity of Carbon Monoxide (DLco)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Forced Vital Capacity (FVC)
Time frame: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Forced Vital Capacity (FVC)
Time frame: Measured after 12 weeks treatment (day 84)
Pre-bronchodilator Slow Vital Capacity (SVC)
Time frame: Measured after 12 weeks treatment (day 84)
Post-bronchodilator Slow Vital Capacity (SVC)
Time frame: Measured after 12 weeks treatment (day 84)
Peak Expiratory Flow (PEF) Morning (Daily Recordings)
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Peak Expiratory Flow (PEF) Evening (Daily Recordings)
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Morning (Daily Recordings)
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Forced Expiratory Volume in 1 Second (FEV1) Evening (Daily Recordings)
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Breathlessness, Cough and Sputum Scale (BCSS) Total Score
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) Total Score
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
St George's Respiratory Questionnaire for COPD Patients (SGRQ-C) Overall Score
Time frame: Measured after 12 weeks treatment (day 84)
Percentage of Reliever Free Days in Last Six Weeks of Treatment
Time frame: Average from measurements recorded daily by patient in last 6 weeks of treatment.
Exacerbations
Time frame: Exacerbations were recorded at all study visits (after 1, 4, 8, and 12 weeks of treatment and at follow up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26043724Nordenmark LH, Taylor R, Jorup C. Feasibility of Computed Tomography in a Multicenter COPD Trial: A Study of the Effect of AZD9668 on Structural Airway Changes. Adv Ther. 2015 Jun;32(6):548-66. doi: 10.1007/s12325-015-0215-3. Epub 2015 Jun 5.
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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.
Professor Asger Dirksen principal investigator
Gentofte Hospital, Department of Lung Medicine
9 sites in 5 countries: 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 9 sites in 5 countries.
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 3 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 20 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Canada, Netherlands, Romania, Ukraine. 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 25 Jul 2012). 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?
AWT-Pi10 (Airway Wall Thickness of a Theoretical Airway With an Internal Perimeter of 10 mm) (time frame: Measured after 12 weeks treatment (day 84)). 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 NCT01054170, 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 20 Aug 2012.