Chronic Obstructive Pulmonary DiseasePhase 2NCT01708057
A Single-dose Study to Investigate the Effects of 4 Different Doses of Inhaled AZD8683 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing AZD8683 and Tiotropium in people with Chronic Obstructive Pulmonary Disease and COPD, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator. 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?
- AZD8683 and Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2012to Dec 2012
- 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
- Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
- Clinical diagnosis of COPD for more than 1 year at Visit 1
- FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC < 70%
- Reversible airway obstruction
Who cannot join
- Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
- Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
- Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
- Long-term oxygen therapy, as judged by the Investigator
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Poland4 sites
Study site
Bialystok
Study site
Lodz
Study site
Proszowice
Study site
Wroclaw
About this study
Official title: A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
Read the detailed description
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- AZD8683, Placebo, Tiotropium
- Keywords
- COPD, Chronic obstructive pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD8683Drug
AZD8683 administered via inhalation
PlaceboDrug
Placebo administered via inhalation
TiotropiumDrug
Tiotropium administered via inhalation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single dose of AZD8683 50 µg Receives: Drug: AZD8683 |
| 2 | Experimental | Single dose of AZD8683 150 µg Receives: Drug: AZD8683 |
| 3 | Experimental | Single dose of AZD8683 300 µg Receives: Drug: AZD8683 |
| 4 | Experimental | Single dose of AZD8683 900 µg Receives: Drug: AZD8683 |
| 5 | Placebo comparator | Single dose of placebo Receives: Drug: Placebo |
| 6 | Active comparator | Single dose of tiotropium 18 µg Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Peak FEV1 (0-24h)
The maximum value over 24 hours post-dose, as change from baseline
Measured: The first 24 hours following dose administration
Change From Baseline in Trough FEV1 (22-26h)
The average over 22 to 26 hours, as change from baseline
Measured: 22 to 26 hours following dose administration
Secondary outcomes (6)
Average FEV1 as a Change From Baseline
Average FEV1 (0-24h): The average over 0 to 24 hours
Measured: The first 24 hours following dose administration
Maximum Increase in Systolic Blood Pressure [SBP]
Maximum (post-dose values - baseline value) for each treatment visit.
Measured: baseline, 24hr post dose
Maximum Increase in Diastolic Blood Pressure [DBP]
Maximum (post-dose values - baseline value) for each treatment visit.
Measured: The first 24 hours following dose administration
Maximum Increase Heart Rate [HR]
Maximum (post-dose values - baseline value) for each treatment visit.
Measured: baseline, 24hr post dose
Maximum Increase in QTcF
maximum (post-dose values - baseline value) for each treatment visit.
Measured: baseline, 24hr post dose
PK Parameters (AZD8683)
Cmax, tmax, AUC
Measured: Pre-dose, 24hr post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
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 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carin Jorup, MD, Study director, AstraZeneca R&DMolndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708057
- Sponsor's protocol ID
- D1883C00007
- Other IDs
- EudraCT number: 2012-002900-42
- Status last verified
- Dec 2013
- First submitted
- 1 Oct 2012
- Last updated
- 15 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind Placebo- and Active-controlled, Multi-centre, 6-way Cross-over, Single-dose Phase IIa Study to Investigate the Bronchodilatory and Systemic Effects of 4 Different Doses of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01708057
- Acronym / sponsor ID
- D1883C00007
- Conditions
- Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- COPD, Chronic obstructive pulmonary disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 Oct 2012 (estimated)
- Results
- Posted 30 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study in Chronic Obstructive Pulmonary Disease (COPD) patients will investigate the bronchodilatory effect of AZD8683. AZD8683 will be tested versus placebo and an active comparator.
Detailed description
A randomised, double-blind placebo- and active-controlled, multi-centre, 6-way cross-over, single-dose phase IIa study to investigate the bronchodilatory and systemic effects of 4 different doses of inhaled AZD8683 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD8683Single dose of AZD8683 50 µg |
| 2 | Experimental | Drug: AZD8683Single dose of AZD8683 150 µg |
| 3 | Experimental | Drug: AZD8683Single dose of AZD8683 300 µg |
| 4 | Experimental | Drug: AZD8683Single dose of AZD8683 900 µg |
| 5 | Placebo comparator | Drug: PlaceboSingle dose of placebo |
| 6 | Active comparator | Drug: TiotropiumSingle dose of tiotropium 18 µg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures Male or female, age ≥ 40 years at Visit 1. Women must be of non-childbearing potential or must have been stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue until follow-up
- Clinical diagnosis of COPD for more than 1 year at Visit 1
- FEV1 ≥ 30 to < 80% of the predicted normal value (post-bronchodilator) at Visit 2 and post-bronchodilator FEV1/FVC < 70%
- Reversible airway obstruction
Key exclusion criteria (5 listed)
- Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study.
- An exacerbation of COPD (defined as use of oral/parenteral glucocorticosteroids (GCS) and/or antibiotics and/or hospitalisation related to COPD) within 6 weeks of Visit 1or during the enrolment period
- Treatment with systemic GCS within 6 weeks of Visit 2 or during the enrolment period
- Respiratory tract infection of clinical relevance within 30 days of Visit 4, as judged by the Investigator
- Long-term oxygen therapy, as judged by the Investigator
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 |
|---|---|---|
| AZD8683AZD8683 administered via inhalation | Drug | 1, 2, 3, 4 |
| PlaceboPlacebo administered via inhalation | Drug | 5 |
| TiotropiumTiotropium administered via inhalation | Drug | 6 |
Primary outcome
Change From Baseline in Peak FEV1 (0-24h)
Time frame: The first 24 hours following dose administration
The maximum value over 24 hours post-dose, as change from baseline
Change From Baseline in Trough FEV1 (22-26h)
Time frame: 22 to 26 hours following dose administration
The average over 22 to 26 hours, as change from baseline
6 secondary outcomes
Average FEV1 as a Change From Baseline
Time frame: The first 24 hours following dose administration
Maximum Increase in Systolic Blood Pressure [SBP]
Time frame: baseline, 24hr post dose
Maximum Increase in Diastolic Blood Pressure [DBP]
Time frame: The first 24 hours following dose administration
Maximum Increase Heart Rate [HR]
Time frame: baseline, 24hr post dose
Maximum Increase in QTcF
Time frame: baseline, 24hr post dose
PK Parameters (AZD8683)
Time frame: Pre-dose, 24hr post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- 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.
Carin Jorup, MD study director
AstraZeneca R&DMolndal, Sweden
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AZD8683 and Tiotropium in people with Chronic Obstructive Pulmonary Disease and COPD, run by AstraZeneca at 6 sites in 2 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, 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 30 Sep 2013). 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?
Change From Baseline in Peak FEV1 (0-24h) (time frame: The first 24 hours following dose administration). 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?
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 15 Jan 2014.