Phase 2
Completed N=213
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
Source: ClinicalTrials.gov NCT02238483 ↗Enrolled (actual)
213
Serious AEs
10.3%
Results posted
Apr 2018
Primary outcomePrimary: Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms — NA; 118.0 days — p=0.2371
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms |
NA; 118.0 | 0.2371 |
| SECONDARY Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo) |
2.16; 1.62 | 0.249 |
| SECONDARY Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause) |
NA; 118.0 | 0.1261 |
| SECONDARY Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause) |
2.17; 1.55 | 0.157 |
| SECONDARY Time to First Moderate or Severe Exacerbation |
NA; NA | 0.1529 |
| SECONDARY Annual Exacerbation Rate of Moderate and Severe Exacerbations |
2.12; 1.42 | 0.129 |
| SECONDARY Time to First Moderate or Severe Exacerbation (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled) |
NA; NA | 0.8543 |
| SECONDARY Annual Exacerbation Rate of Moderate and Severe Exacerbations (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled) |
1.23; 1.09 | 0.751 |
| SECONDARY Time to First Symptom Defined Exacerbation (as Defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] Daily Diary) |
NA; NA | 0.5381 |
| SECONDARY Annual Exacerbation Rate of Symptom Defined Exacerbations (as Defined by the EXACT Daily Diary) |
1.96; 2.33 | 0.440 |
| SECONDARY Symptoms of COPD (Using the EXACT for Respiratory Symptoms [E-RS] Total Score, a Subset of Items From the EXACT Diary) |
-0.21; 0.17 | 0.5474 |
| SECONDARY Health Related Quality of Life (as Assessed by St Georges Respiratory Questionnaire for COPD Patients [SGRQ-C]) |
-4.03; -5.11 | 0.6352 |
| SECONDARY Dyspnea (Transitional Dyspnea Index (TDI) Score) |
0.41; 0.54 | 0.2694 |
| SECONDARY Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Expiratory Volume in 1 Second (FEV1) |
-0.003; -0.028 | 0.5144 |
| SECONDARY Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Vital Capacity (FVC) |
-0.045; -0.018 | 0.5416 |
| SECONDARY Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough FEV1/FVC Ratio |
0.0077; -0.0072 | 0.1965 |
Eligibility Criteria
Inclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT02238483). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.