Chronic Obstructive Pulmonary Disease (COPD)Phase 2TOPNCT00629239
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing AZD4818 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 12 sites in 5 countries.
Trial summary
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AZD4818
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 12 sitesin 5 countries
- Study dates
- Jan 2008to Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Who cannot join
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Denmark3 sites
Research Site
Hvidovre
Research Site
København NV
Research Site
Odense C
Finland3 sites
Research Site
Helsinki
Research Site
Preitilä
Research Site
Tampere
About this study
Official title: A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
- Being tested
- AZD4818, Placebo
- Keywords
- COPD, tolerability, inhalation
- 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.
AZD4818Drug
Dry Powder, inhalation, b.i.d., 4 weeks
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD4818 Receives: Drug: AZD4818 |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Experiencing Adverse Events
Number of patients who had an Adverse Event
Measured: At all study visits
Secondary outcomes (13)
Forced Expiratory Volume 1 (FEV1)
Change in (FEV1) from baseline to end of treatment
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)
Change in FVC from baseline to end of treatment
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)
Change in VC from baseline to end of treatment
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Inspiratory Capacity (IC)
Change from IC baseline to end of treatment
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Expiratory Flow (FEF) 25%-75%
Change in FEF from baseline to end of treatment
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Change from average during run-in to average during treatment
Measured: Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Change in PEF from average during run-in to average during treatment
Measured: Daily during run-in and treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Change from baseline to end of treatment in score , The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited)
Measured: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Measured: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Measured: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Change from average during run-in to average during treatment. Scores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Measured: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Change from average during run-in to average during treatmentScores on a Scale, 5-point Likert-type scale, ranging from 0 (none) to 4 (severe).
Measured: Daily during run-in and treatment
6-minute Walk Test
Change from baseline to end of treatment
Measured: Before treatment and after 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionAug 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Huib AM Kerstjens, MD, PhD, Principal investigator, University Medical Centre, Groningen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629239
- Sponsor's protocol ID
- D3540C00005
- Acronym
- TOP
- Status last verified
- Nov 2010
- First submitted
- 25 Feb 2008
- Last updated
- 6 Dec 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Double-blind, Placebo-controlled, Randomized, Parallel Group Phase IIa Study to Assess the Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00629239
- Acronym / sponsor ID
- TOP / D3540C00005
- Keywords
- COPD, tolerability, inhalation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Posted 6 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 see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.
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 |
|---|---|---|
| 1 | Experimental | Drug: AZD4818AZD4818 |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of COPD, with symptoms for more than 1 year
- Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
- Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator
Key exclusion criteria (3 listed)
- Clinical suspicion of active tuberculosis
- Any current clinically significant respiratory tract disorder other than COPD
- History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
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 |
|---|---|---|
| AZD4818Dry Powder, inhalation, b.i.d., 4 weeks | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Number of Patients Experiencing Adverse Events
Time frame: At all study visits
Number of patients who had an Adverse Event
13 secondary outcomes
Forced Expiratory Volume 1 (FEV1)
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Vital Capacity (FVC)
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Vital Capacity (VC)
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Inspiratory Capacity (IC)
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Forced Expiratory Flow (FEF) 25%-75%
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Peak Expiratory Flow (PEF) Morning
Time frame: Daily during run-in and treatment
Peak Expiratory Flow (PEF) Evening
Time frame: Daily during run-in and treatment
The Clinical COPD ( Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) Total
Time frame: Before treatment and after 1, 2, 3 and 4 weeks of treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Breathlessness
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Chest Tightness
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Cough Score
Time frame: Daily during run-in and treatment
Chronic Obstructive Pulmonary Disease (COPD) Symptoms, Sleep Score
Time frame: Daily during run-in and treatment
6-minute Walk Test
Time frame: Before treatment and after 4 weeks of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2010.
- 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.
Huib AM Kerstjens, MD, PhD principal investigator
University Medical Centre, Groningen, The Netherlands
12 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 AZD4818 in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 12 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 6 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Denmark, Finland, Norway, Netherlands, 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 6 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?
Number of Patients Experiencing Adverse Events (time frame: At all study visits). 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 6 Dec 2010.