Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT02109406
Efficacy and Safety Study of Two Dose Levels of AZD2115 in Subjects With Moderate to Severe COPD
A Phase 2 study testing AZD2115 Dose 1 and AZD 2115, Dose 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 3 sites in United States.
Trial summary
This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- AZD2115 Dose 1 and AZD 2115, Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2014to Sep 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
- Current or former smokers with a history of ≥10 pack years of cigarette smoking.
- Post-bronchodilator FEV1/FVC ratio of <70%.
- Pre-bronchodilator FEV1 must be <80% predicted
- Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.
Who cannot join
- Pregnancy: Women who are pregnant or lactating.
- Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Primary diagnosis of asthma.
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
- Poorly controlled COPD (hospitalization due to poorly controlled COPD within 3 months of Screening or requiring treatment with corticosteroids or antibiotics in the 6 week interval prior to Screening or during Screening.
- Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of Randomization.
- Clinically significant abnormal ECG.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Pearl Therapeutics Study Site
Charleston, South Carolina
Pearl Therapeutics Study Site
Clearwater, Florida
Pearl Therapeutics Study Site
Spartanburg, South Carolina
About this study
Official title: A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD
This is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
- Being tested
- AZD2115 Dose 1, AZD 2115, Dose 2, Placebo MDI
- 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.
AZD2115 Dose 1Drug
AZD 2115, Dose 1 administered as two inhalations BID
AZD 2115, Dose 2Drug
AZD 2115, Dose 2 administered as two inhalations BID
Placebo MDIDrug
Placebo MDI administered as two inhalations BID
| Study group | Role | What they receive |
|---|---|---|
| AZD2115 Dose 1 | Experimental | AZD 2115, Dose 1 administered as two inhalations BID Receives: Drug: AZD2115 Dose 1 |
| AZD 2115 Dose 2 | Experimental | AZD 2115, Dose 2 administered as two inhalations BID Receives: Drug: AZD 2115, Dose 2 |
| Placebo MDI | Placebo comparator | Placebo MDI administered as two inhalations BID Receives: Drug: Placebo MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
Measured: 14 Days
Secondary outcomes (6)
Change from baseline in morning pre dose trough FEV1
Measured: 14 Days
Peak change in FEV1
Measured: 14 Days
Forced vital capacity (FVC) AUC0-12 relative to baseline
Measured: 14 Days
Peak change in FEV1
Measured: Day 1
Change from baseline in 12-hour post dose trough FEV1
Measured: 14 Days
Time to onset of action
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearl Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shahid Siddiqui, MD, Study director, Pearl Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109406
- Sponsor's protocol ID
- AZD2115 D3060C00006
- Status last verified
- Aug 2020
- First submitted
- 2 Apr 2014
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Chronic Dosing (14 Days), Three Period, Placebo Controlled, Cross Over, Multi Center Study to Assess Efficacy and Safety of Two Dose Levels of AZD2115 MDI in Subjects With Moderate to Severe COPD
- ClinicalTrials.gov ID
- NCT02109406
- Acronym / sponsor ID
- AZD2115 D3060C00006
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pearl Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Apr 2014 (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 is a phase IIa dose-ranging, randomized, double-blind, chronic-dosing (14 Days), three-period, placebo-controlled, multi-center, cross-over study to assess the efficacy and safety of two dose levels of a dual pharmacology molecule with the combined properties of a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA); (AZD2115) delivered by a metered-dose inhaler (MDI) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AZD2115 Dose 1 | Experimental | Drug: AZD2115 Dose 1AZD 2115, Dose 1 administered as two inhalations BID |
| AZD 2115 Dose 2 | Experimental | Drug: AZD 2115, Dose 2AZD 2115, Dose 2 administered as two inhalations BID |
| Placebo MDI | Placebo comparator | Drug: Placebo MDIPlacebo MDI administered as two inhalations BID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic Obstructive Pulmonary Disease Diagnosis: Subjects with an established clinical history of COPD for more than 1 year at Screening, according to the COPD GOLD guidelines.
- Current or former smokers with a history of ≥10 pack years of cigarette smoking.
- Post-bronchodilator FEV1/FVC ratio of <70%.
- Pre-bronchodilator FEV1 must be <80% predicted
- Women of non-child bearing potential (ie., physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or women of child bearing potential, has a negative serum pregnancy test at Screening and agrees to acceptable contraceptive methods for the duration of the study.
Key exclusion criteria (8 listed)
- Pregnancy: Women who are pregnant or lactating.
- Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Primary diagnosis of asthma.
- Alpha-1 antitrypsin deficiency as the cause of COPD
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea.
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 |
|---|---|---|
| AZD2115 Dose 1AZD 2115, Dose 1 administered as two inhalations BID | Drug | AZD2115 Dose 1 |
| AZD 2115, Dose 2AZD 2115, Dose 2 administered as two inhalations BID | Drug | AZD 2115 Dose 2 |
| Placebo MDIPlacebo MDI administered as two inhalations BID | Drug | Placebo MDI |
Primary outcome
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline
Time frame: 14 Days
6 secondary outcomes
Change from baseline in morning pre dose trough FEV1
Time frame: 14 Days
Peak change in FEV1
Time frame: 14 Days
Forced vital capacity (FVC) AUC0-12 relative to baseline
Time frame: 14 Days
Peak change in FEV1
Time frame: Day 1
Change from baseline in 12-hour post dose trough FEV1
Time frame: 14 Days
Time to onset of action
Time frame: Day 1
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 2 Sep 2020.
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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.
Shahid Siddiqui, MD study director
Pearl Therapeutics, Inc.
3 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 AZD2115 Dose 1 and AZD 2115, Dose 2 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Pearl Therapeutics, Inc. at 3 sites in United States.
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 8 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 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12) relative to baseline (time frame: 14 Days). 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 2 Sep 2020.