Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT01205269

The Study Will Evaluate the Effect of AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Phase 2 study testing AZD8683, 50 mcg and AZD8683, 200 mcg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients. 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, 50 mcg and AZD8683, 200 mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 4 sitesPoland
Study dates: Oct 2010to Dec 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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Clinical diagnosis of COPD
Current or ex-smokers
FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Who cannot join

Any clinically significant disease or disorder
Any clinically relevant abnormal findings at screening examinations
Family history or presence of glaucoma
Need of long term oxygen therapy

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

Research Site
Bialystok
Research Site
Bydgoszcz
Research Site
Lodz
Research Site
Proszowice

Other trials in Poland

About this study

Official title: A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Read the detailed description

A double-blind, placebo-controlled, randomised, multi-centre, 3-way cross-over, single-dose phase II study to investigate the local and systemic effects of inhaled AZD8683 in patients with chronic obstructive pulmonary disease (COPD)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: AZD8683, 50 mcg, Placebo, AZD8683, 200 mcg
Keywords: Chronic Obstructive Pulmonary Disease (COPD), 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.

AZD8683, 50 mcgDrug
Dry powder for inhalation, single dose
PlaceboDrug
Dry powder for inhalation, single dose
AZD8683, 200 mcgDrug
Dry powder for inhalation, single dose

Study groups in NCT01205269
Study group	Role	What they receive
First 50 mcg, then 200 mcg, then placebo	Experimental	period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg
First 50 mcg, then placebo, then 200 mcg	Experimental	period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg
First 200 mcg, then placebo, then 50 mcg	Experimental	period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg
First 200 mcg, then 50 mcg, then placebo	Experimental	period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg
First placebo, then 200 mcg, then 50 mcg	Experimental	period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg
First placebo, then 50 mcg, then 200 mcg	Experimental	period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg Receives: Drug: AZD8683, 50 mcg; Drug: Placebo; Drug: AZD8683, 200 mcg

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, 5 min, 15 min, 30 min, 1 h, 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, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
Maximum FVC value
Measured: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
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. QTcF = QT interval corrected for heart rate using Fridericia's formula
Measured: 0, 30 min, 2 h, 4 h
Plasma AZD8683 Cmax
Maximum plasma concentration of AZD8683
Measured: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD8683 AUC0-24
Area under the AZD8683 plasma concentration curve from 0 to 24 hours
Measured: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 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.

Oct 2010Dec 2010

First posted20 Sep 2010 (estimated)
Study startOct 2010
Primary completionDec 2010
Study completionDec 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.
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: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01205269
Sponsor's protocol ID: D1883C00004
Other IDs: EudraCT number: 2010-020506-15
Status last verified: Feb 2014
First submitted: 15 Sep 2010
Last updated: 19 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Obstructive Pulmonary Disease (COPD) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Placebo-controlled, Randomised, Multi-centre, 3-way Cross-over, Single-dose Phase II Study to Investigate the Local and Systemic Effects of Inhaled AZD8683 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01205269
Acronym / sponsor ID: D1883C00004
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease (COPD), safety, inhalation, long-acting muscarinic receptor antagonist (LAMA)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 20 Sep 2010 (estimated)
Results: Posted 13 Nov 2013

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 investigate effects of inhaled AZD8683 compared to placebo in COPD patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 6

Arm	Type	Receives
First 50 mcg, then 200 mcg, then placebo	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4:washout, period5: placebo
First 50 mcg, then placebo, then 200 mcg	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
First 200 mcg, then placebo, then 50 mcg	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
First 200 mcg, then 50 mcg, then placebo	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
First placebo, then 200 mcg, then 50 mcg	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
First placebo, then 50 mcg, then 200 mcg	Experimental	Drug: AZD8683, 50 mcg, Drug: Placebo, Drug: AZD8683, 200 mcgperiod 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg

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
Current or ex-smokers
FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post-bronchodilator FEV1/FVC < 70%

Key exclusion criteria (4 listed)

Any clinically significant disease or disorder
Any clinically relevant abnormal findings at screening examinations
Family history or presence of glaucoma
Need of long term oxygen therapy

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
AZD8683, 50 mcgDry powder for inhalation, single dose	Drug	First 200 mcg, then 50 mcg, then placebo, First 200 mcg, then placebo, then 50 mcg, First 50 mcg, then 200 mcg, then placebo, First 50 mcg, then placebo, then 200 mcg, First placebo, then 200 mcg, then 50 mcg, First placebo, then 50 mcg, then 200 mcg
PlaceboDry powder for inhalation, single dose	Drug	First 200 mcg, then 50 mcg, then placebo, First 200 mcg, then placebo, then 50 mcg, First 50 mcg, then 200 mcg, then placebo, First 50 mcg, then placebo, then 200 mcg, First placebo, then 200 mcg, then 50 mcg, First placebo, then 50 mcg, then 200 mcg
AZD8683, 200 mcgDry powder for inhalation, single dose	Drug	First 200 mcg, then 50 mcg, then placebo, First 200 mcg, then placebo, then 50 mcg, First 50 mcg, then 200 mcg, then placebo, First 50 mcg, then placebo, then 200 mcg, First placebo, then 200 mcg, then 50 mcg, First placebo, then 50 mcg, then 200 mcg

Primary outcome

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose
Time frame: 0, 5 min, 15 min, 30 min, 1 h, 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, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
Forced Vital Capacity (FVC), Peak Effect Over 0 - 24 Hours Post-dose
Time frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h
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 AZD8683 Cmax
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h
Plasma AZD8683 AUC0-24
Time frame: 0, 5 min, 15 min, 30 min, 45 min, 1 h, 90 min, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h

Results and safety

Results posted to the registry on 13 Nov 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First 50 mcg, Then 200 mcg, Then Placebo	4	4
First 50 mcg, Then Placebo, Then 200 mcg	4	4
First 200 mcg, Then Placebo, Then 50 mcg	4	4
First 200 mcg, Then 50 mcg, Then Placebo	6	6
First Placebo, Then 200 mcg, Then 50 mcg	5	5
First Placebo, Then 50 mcg, Then 200 mcg	5	5

Primary outcome: Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose

Time frame: 0, 5 min, 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 18 h, 22 h, 24 h. Mean (Standard Deviation). Unit: L

Measure	AZD8683 50 mcg n = 28	AZD8683 200 mcg n = 28	Placebo n = 27
Value	1.67 (0.48)	1.73 (0.47)	1.64 (0.47)

Population analysed: Of the 28 randomised patients, 27 completed the study and one discontinued during the last washout period. All 28 randomised patients were included in the analyses of all variables

Primary outcome: Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose

Time frame: 22 h, 24 h, 26 h. Mean (Standard Deviation). Unit: L

Measure	AZD8683 50 mcg n = 28	AZD8683 200 mcg n = 28	Placebo n = 27
Value	1.53 (0.46)	1.60 (0.46)	1.49 (0.46)

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD8683 50 mcg	0 of 28 (0%)	0 of 28 (0%)	Not reported
AZD8683 200 mcg	0 of 28 (0%)	0 of 28 (0%)	Not reported
Placebo	0 of 27 (0%)	0 of 27 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Obstructive Pulmonary Disease (COPD)

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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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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.

Piotr Kuna, MD Professor principal investigator

Poland

4 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 AZD8683, 50 mcg and AZD8683, 200 mcg in people with Chronic Obstructive Pulmonary Disease (COPD), run by AstraZeneca at 4 sites in Poland.

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 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. 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. 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 13 Nov 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?

Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose (time frame: 0, 5 min, 15 min, 30 min, 1 h, 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 NCT01205269.

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 19 Mar 2014.