AzTrials
AzTrials

Chronic Obstructive Pulmonary Disease COPDPhase 2NCT02238483

A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy

A Phase 2 study testing AZD7624 1.0 mg in people with Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 41 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether AZD7624 can reduce acute Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy with a history of frequent acute exacerbations. Read more about this study

Who is it for?
Ages 40 to 85 years
What is being tested?
AZD7624 1.0 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
213 participants
Where
41 sitesin 6 countries
Study dates
28 Oct 2014to 4 Apr 2016
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated written informed consent prior to any study specific procedures.
  • Male and females aged 40-85 years. Females must have a negative pregnancy test at Visit 1, must not be lactating and must be of non-childbearing potential. Males must be surgically sterile or agree to use an acceptable method of contraception for the duration of the study and for 3 months after the last dose of investigational product to prevent pregnancy in a partner.
  • A weight of ≥50 kg.
  • Diagnosis of COPD for more than 1 year at Visit 1, according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2014 guidelines.
  • COPD maintenance treatment with at least ICS/LABA for at least 2 months prior to enrolment to be continued unchanged during the study.
  • A post-bronchodilator FEV1/FVC <0.70 and a post-bronchodilator FEV1 ≤70% of the predicted normal value. Documented history of 2 or more moderate to severe COPD exacerbations within 12 months of randomisation, but not within the last 6 weeks before randomisation.
  • Current or ex-smokers with a smoking history of at least 10 pack-years.

Who cannot join

  • Involvement in the planning and conduct of the study.
  • Previous randomisation in the present study.
  • Participation in another clinical study with any investigational medicinal product within 3 months of randomisation. Previously intake of any p38 inhibitor.
  • Participation in, or scheduled for an intensive COPD rehabilitation programme at any time during the study.
  • Planned in-patient surgery or hospitalisation during the study.
  • Significant disease or disorder other than COPD which, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study. Asthma as a primary or main diagnosis according to the Global Initiative for Asthma (GINA) guidelines (GINA 2013) or other accepted guidelines.
Show all 22Show fewer
  • A clinically relevant abnormal findings in clinical chemistry, haematology and urinalysis.
  • Plasma myoglobin and CK above the upper reference range of the analysing laboratory at randomization.
  • A clinically relevant abnormal findings in physical examination, pulse or blood pressure.
  • A positive result on screening for serum hepatitis B hepatitis C and Human Immunodeficiency Virus (HIV).
  • History or family history of muscle diseases. Abnormal vital signs, defined as Systolic Blood Pressure (SBP) above 140 mmHg if <60 years of age and above 150 mmHg if ≥60 years of age; Diastolic Blood Pressure (DBP) above 90 mmHg; Pulse <50 or >100 bpm.
  • Prolonged QTcF >450 ms or family history of long QT syndrome or sudden death at young age. PR(PQ) interval of clinical significance, PR(PQ) > 250 ms.
  • Intermittent AV block of 2nd and 3rd degree or AV dissociation.
  • Patients with a QRS duration >120 ms.
  • Patients with persistent, and/or recurrent symptomatic tachyarrhythmias, as well as patients with an implantable cardioverter-defibrillator (ICD) or a permanent pacemaker.
  • Patients with recent Cardiovascular (CV) events or unstable CV disease or a myocardial infarction or stroke within 6 months of screening. History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II.
  • History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7624.
  • Any exacerbation or respiratory infection within 6 weeks of randomization.
  • Plasma donation within one month of Visit 1, or any blood donation/blood loss >500 mL during the 3 months prior to Visit 1.
  • History of, or current alcohol or drug abuse.
  • Treatment with any GCS (apart from prescribed steroids at run-in) within 6 weeks of Visit 3 regardless of indication.
  • Treatment with strong CYP3A inhibitors within 4 weeks prior to randomisation.

Trial locations and contacts

41 sites in 6 countries.

41 sites in 6 countries

United States20 sites

  • Research Site

    Akron, Ohio, 44302

  • Research Site

    Atlanta, Georgia, 30310

  • Research Site

    Baltimore, Maryland, 21224

  • Research Site

    Blue Ridge, Georgia, 30513

  • Research Site

    Charlotte, North Carolina, 28207

  • Research Site

    Dayton, Ohio, 45459

  • Research Site

    Denver, Colorado, 80206

  • Research Site

    Erie, Pennsylvania, 16508

  • Research Site

    Gaffney, South Carolina, 29340

  • Research Site

    Greenville, South Carolina, 29605

  • Research Site

    Hialeah, Florida, 33013

  • Research Site

    Kingwood, Texas, 77339

  • Research Site

    Larchmont, New York, 10538

  • Research Site

    Los Angeles, California, 90036

  • Research Site

    Miami, Florida, 33176

  • Research Site

    Pembroke Pines, Florida, 33024

  • Research Site

    Rock Hill, South Carolina, 29732

  • Research Site

    St Louis, Missouri, 63141

  • Research Site

    Torrance, California, 90505

  • Research Site

    Wilmington, North Carolina, 28401

Other trials in United States

South Africa6 sites

  • Research Site

    Cape Town, 7764

  • Research Site

    eManzimtoti, 4126

  • Research Site

    Johannesburg, 1818

  • Research Site

    Johannesburg, 2001

  • Research Site

    Mount Edgecombe, 4302

  • Research Site

    Parktown West, 2193

Other trials in South Africa

Argentina5 sites

  • Research Site

    Buenos Aires, C1414AIF

  • Research Site

    CABA, C1425BEN

  • Research Site

    Ciudad Autónoma de Bs. As., 1426

  • Research Site

    Quilmes, B1878FNR

  • Research Site

    San Miguel de Tucumán, 4000

Other trials in Argentina

Chile4 sites

  • Research Site

    Santiago, 7980378

  • Research Site

    Santiago, 8380453

  • Research Site

    Talca, 3465584

  • Research Site

    Talcahuano, 4270918

Other trials in Chile

Netherlands4 sites

  • Research Site

    Assen, 9401 RK

  • Research Site

    Heerlen, 6419 PC

  • Research Site

    Nijmegen, 6525 GA

  • Research Site

    Zutphen, 7207 AE

Other trials in Netherlands

Peru2 sites

  • Research Site

    Lima, L 41

  • Research Site

    Lima, LIMA 21

Other trials in Peru

About this study

Official title: A 12-week Phase IIa, Double-blind, Placebo-controlled, Randomized Study to Investigate the Efficacy and Safety of AZD7624 in COPD Patients With a History of Frequent Acute Exacerbations While on Maintenance Therapy

The purpose of this study is to determine whether AZD7624 can reduce acute Chronic Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy with a history of frequent acute exacerbations.

Being tested
AZD7624 1.0 mg, Placebo
Keywords
Chronic Obstructive Pulmonary Disease, COPD patients, Exacerbations, ICS, LABA
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.

  • AZD7624 1.0 mgDrug

    Inhaled AZD7624 solution, 11 mg/mL

  • PlaceboDrug

    Inhaled placebo solution

Study groups in NCT02238483
Study groupRoleWhat they receive
AZD7624ExperimentalActive treatment
Receives: Drug: AZD7624 1.0 mg
PlaceboPlacebo comparatorPlacebo Comparator
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

Secondary outcomes (15)

  1. Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)

    For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.

    Annual Event Rate = No. of Events*365.25 / (Follow-up date - Date of randomization + 1).

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  2. Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  3. Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)

    For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below.

    Annual Event Rate = No. of Events*365.25 / (Follow-up date - Date of randomization + 1).

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  4. Time to First Moderate or Severe Exacerbation

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  5. Annual Exacerbation Rate of Moderate and Severe Exacerbations

    For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.

    Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1).

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  6. Time to First Moderate or Severe Exacerbation (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  7. Annual Exacerbation Rate of Moderate and Severe Exacerbations (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)

    For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.

    Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1).

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  8. Time to First Symptom Defined Exacerbation (as Defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] Daily Diary)

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  9. Annual Exacerbation Rate of Symptom Defined Exacerbations (as Defined by the EXACT Daily Diary)

    For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below.

    Annual Exacerbation Rate = No. of Exacerbations*365.25 / (Follow-up date - Date of randomization + 1).

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  10. Symptoms of COPD (Using the EXACT for Respiratory Symptoms [E-RS] Total Score, a Subset of Items From the EXACT Diary)

    The EXACT for Respiratory Symptoms (E-RS) scale is a derivative instrument comprising a subset of 11 of the EXACT items to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  11. Health Related Quality of Life (as Assessed by St Georges Respiratory Questionnaire for COPD Patients [SGRQ-C])

    The SGRQ-C is a modified version of the St. George's Respiratory Questionnaire, which has been developed to measure the impact of respiratory disease on health status. The SGRQ-C includes 14 questions in 3 domains: symptoms; activity; and impacts. Scores range from 0 to 100 with higher scores indicating benefit. Change in total score from pre study-treatment baseline to Week 12 end of treatment visit are reported.

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  12. Dyspnea (Transitional Dyspnea Index (TDI) Score)

    The Baseline/Transitional Dyspnea Index (BDI/TDI) provides a multidimensional measure of dyspnea in relation to activities of daily living. The BDI provides a measure of dyspnoea at a single state, the baseline, and the TDI evaluates changes in dyspnoea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference.

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  13. Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Expiratory Volume in 1 Second (FEV1)

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  14. Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Vital Capacity (FVC)

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

  15. Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough FEV1/FVC Ratio

    Measured: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2014 (estimated)
  2. Study start28 Oct 2014
  3. Primary completion4 Apr 2016
  4. Study completion4 Apr 2016

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
213 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02238483
Sponsor's protocol ID
D2550C00005
Other IDs
2014-001053-16, 2014
Status last verified
Apr 2018
First submitted
1 Sep 2014
Last updated
24 May 2018
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD7624 1.0 mg in people with Chronic Obstructive Pulmonary Disease COPD, run by AstraZeneca at 41 sites in 6 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 7 inclusion and 22 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 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, South Africa, Argentina, Chile, Netherlands and 1 more country. 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 18 Apr 2018). 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?

Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms (time frame: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)). 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 NCT02238483.

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 24 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in