COPDPhase 2NCT01498081
A Single-dose Study to Investigate the Effects of 3 Different Doses of Inhaled AZD2115 in COPD Patients
A Phase 2 study testing AZD2115, Indacaterol and Indacaterol + Tiotropium in people with COPD, run by AstraZeneca at 6 sites in 2 countries.
Trial summary
This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- AZD2115, Indacaterol and Indacaterol + Tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2012to Oct 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
- Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
- Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value 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 within 6 weeks prior to Visit 1
- Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
- Recent or ongoing respiratory tract infection during enrolment period.
- Need for long-term oxygen therapy and/or saturation O2 < 92%.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Poland4 sites
Research Site
Bialystok
Research Site
Łęczna
Research Site
Lodz
Research Site
Proszowice
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 Local and Systemic Effects of 3 Different Doses of Inhaled AZD2115 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study in COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.
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 local and systemic effects of 3 different doses of inhaled AZD2115 in patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- COPD
- Being tested
- AZD2115, Placebo, Indacaterol, Indacaterol + Tiotropium
- Keywords
- COPD, pulmonary disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2115Drug
AZD2115 administered via inhalation
PlaceboDrug
Placebo administered via inhalation
IndacaterolDrug
Indacaterol administered via inhalation
Indacaterol + TiotropiumDrug
Indacaterol + Tiotropium administered inhalation
| Study group | Role | What they receive |
|---|---|---|
| Single dose of AZD2115 25 µg | Experimental | Not described Receives: Drug: AZD2115 |
| Single dose of AZD2115 80 µg | Experimental | Not described Receives: Drug: AZD2115 |
| Single dose of AZD2115 240 µg | Experimental | Not described Receives: Drug: AZD2115 |
| Single doses of placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Single dose of indacaterol 150 µg | Active comparator | Not described Receives: Drug: Indacaterol |
| Single dose of indacaterol 150 µg + tiotropium 18 µg | Active comparator | Not described Receives: Drug: Indacaterol + Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments
Measured: During the first 24 hours following administration
Trough FEV1defined as the average FEV1 from the spirometry assessments
Measured: During 22 to 26 hours following administration
Secondary outcomes (7)
Average FEV1
Measured: FEV1 0-24h post-dose
Peak, average and trough Forced Vital Capacity (FVC)
Measured: FVC peak and average 0-24h post-dose and trough 22-26h post-dose
Systemic effect by assessment of blood pressure (BP)
Measured: Peak and average 0-4 h post dose
Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)
Measured: Peak and average 0-4 h post dose
Systemic effect by assessment of Potassium and Glucose
Measured: Peak and average 0-4 h post dose
Safety and tolerability of 3 different single doses of AZD2115
Measured: At screening, during 0-26 h post-dose and at follow-up
Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax)
Measured: 0-24h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 39 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&D Molndal, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498081
- Sponsor's protocol ID
- D3060C00003
- Other IDs
- EudraCT number: 2011-004641-41
- Status last verified
- Oct 2012
- First submitted
- 21 Dec 2011
- Last updated
- 26 Oct 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. 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 Local and Systemic Effects of 3 Different Doses of Inhaled AZD2115 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01498081
- Acronym / sponsor ID
- D3060C00003
- Conditions
- COPD
- Keywords
- COPD, pulmonary disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
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 COPD patients will investigate the bronchodilatory effect of AZD2115. AZD2115 will be tested versus placebo and active comparators. The safety and tolerability of AZD2115 including investigations of clinically relevant systemically mediated effects will also be investigated.
Detailed description
A randomised, double-blind, placebo and active controlled, multi-centre, 6 way cross-over, single-dose Phase IIa study to investigate the local and systemic effects of 3 different doses of inhaled AZD2115 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 |
|---|---|---|
| Single dose of AZD2115 25 µg | Experimental | Drug: AZD2115 |
| Single dose of AZD2115 80 µg | Experimental | Drug: AZD2115 |
| Single dose of AZD2115 240 µg | Experimental | Drug: AZD2115 |
| Single doses of placebo | Placebo comparator | Drug: Placebo |
| Single dose of indacaterol 150 µg | Active comparator | Drug: Indacaterol |
| Single dose of indacaterol 150 µg + tiotropium 18 µg | Active comparator | Drug: Indacaterol + Tiotropium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study specific procedures
- Male or female of non-childbearing potential (post-menopausal or surgically sterilised), age ≥40 years at Visit 1
- Clinical diagnosis of COPD for more than 1 year at Visit 1, according to GOLD guidelines
- Post-bronchodilator FEV1 ≥ 40 to < 80% of the predicted normal value 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 within 6 weeks prior to Visit 1
- Treatment with systemic glucocorticosteroids with 6 weeks of Visit 2.
- Recent or ongoing respiratory tract infection during enrolment period.
- Need for long-term oxygen therapy and/or saturation O2 < 92%.
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 |
|---|---|---|
| AZD2115AZD2115 administered via inhalation | Drug | Single dose of AZD2115 240 µg, Single dose of AZD2115 25 µg, Single dose of AZD2115 80 µg |
| PlaceboPlacebo administered via inhalation | Drug | Single doses of placebo |
| IndacaterolIndacaterol administered via inhalation | Drug | Single dose of indacaterol 150 µg |
| Indacaterol + TiotropiumIndacaterol + Tiotropium administered inhalation | Drug | Single dose of indacaterol 150 µg + tiotropium 18 µg |
Primary outcome
Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments
Time frame: During the first 24 hours following administration
Trough FEV1defined as the average FEV1 from the spirometry assessments
Time frame: During 22 to 26 hours following administration
7 secondary outcomes
Average FEV1
Time frame: FEV1 0-24h post-dose
Peak, average and trough Forced Vital Capacity (FVC)
Time frame: FVC peak and average 0-24h post-dose and trough 22-26h post-dose
Systemic effect by assessment of blood pressure (BP)
Time frame: Peak and average 0-4 h post dose
Systemic effect by assessment of heart rate (HR) and QT interval corrected for heart rate using Fridericia's formula (QTcF)
Time frame: Peak and average 0-4 h post dose
Systemic effect by assessment of Potassium and Glucose
Time frame: Peak and average 0-4 h post dose
Safety and tolerability of 3 different single doses of AZD2115
Time frame: At screening, during 0-26 h post-dose and at follow-up
Plasma concentrations of AZD2115 after 3 different single doses measured as area under the curve over the time (AUC) and maximum concentration (Cmax), and time to maximum concentration (tmax)
Time frame: 0-24h post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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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&D Molndal, 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 AZD2115, Indacaterol and Indacaterol + Tiotropium in people with 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 5 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: finished, as of the sponsor's last update on 26 Oct 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak Forced Expiratory Volume in 1 second (FEV1) defined as the maximum FEV1 from the spirometry assessments (time frame: During the first 24 hours following 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 26 Oct 2012.