This is a randomized, placebo-controlled, double-blind study meaning neither the patient nor the study doctor will know which medication is being given. The study is randomized, meaning that participants will be assigned to 1 of 3 treatment groups without any premeditated order. AZD8871 is administered once daily during two weeks in patients with moderate to severe COPD to evaluate its efficacy, how it is absorbed in the blood stream and its safety.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 20.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2018-001722-25-GB
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
1. Provision of signed and dated, written ICF prior to any study-specific procedures, sampling, and analyses.
2. Patient must be 40 to 85 years of age (both inclusive) at the time of signing the ICF (Screening; Visit 1).
3. COPD Diagnosis: Patient with an established clinical history of moderate to severe COPD for more than 1 year at Screening, according to the GOLD COPD guidelines.
4. Tobacco Use: Patient is a current or former smoker with a history of =10 pack-years of cigarette smoking [Number of pack-years=(number of cigarettes per day/20)* number of years smoked (eg, 1 pack-year=20 cigarettes smoked per day for 1 year)]. A former smoker is defined as one who has stopped smoking for at least 6 months prior to Screening.
- Patient smoking other tobacco types (including e-cigarettes) will not be allowed, unless he/she meets the cigarette criterion as well.
5. Patient with post-bronchodilator FEV1/forced vital capacity (FVC) ratio <70% based on the value reached after inhalation of salbutamol (400 µg) at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day -14.
6. Patient with post-bronchodilator FEV1 that must be =40% and <80% predicted normal value at Visit 2. If criterion is not met, the test can be repeated at the latest, up to Day -14.
7. Patient is willing and, in the opinion of the Investigator, able to change current COPD therapy as required by the protocol and willing to use ipratropium following the approved dosage and regimen (during run-in and wash-out periods) with or without ICS for maintenance therapy of COPD and rescue medication salbutamol (as needed) from Visit 1 to Visit 11.
8. Patient must be able to read, speak and understand local language, and be willing to remain at the study centre as required per-protocol to complete all visit assessments.
9. Body mass index (BMI) <40 kg/m2 at the time of Screening.
10. Male and/or females of non-childbearing potential who are not pregnant or lactating.
11. Female patients must be of non-childbearing potential defined as:
- Permanently or surgically sterilised, including hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy.
- Post-menopausal; aged <50 years and amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the post menopausal range of the local laboratory.
- Post-menopausal; aged =50 years and amenorrhoeic for 12 months or more, following cessation of all exogenous hormonal treatments.
12.Male patients should use a condom and spermicide (or sexual abstinence*) to prevent pregnancy and drug exposure of a partner, regardless of the gender or childbearing potential of the partner from the day of the first administration of the IP until 3 months after the last administration of the IP. In addition to a condom with spermicide, a second highly effective method of contraception (oral, intravaginal or transdermal hormonal contraceptives, intrauterine device, or intrauterine hormone-releasing system until 3 months after the last administration of the IP) should be used with female partners of childbearing potential. Double barrier methods (a combination
1. Patient has significant diseases other than COPD, (ie, clinically relevant disease or condition or an abnormality in prior ECGs, medical history or physical examinations) which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patient's ability to participate in the study.
2. Patient has alpha-1 antitrypsin deficiency as the cause of COPD.
3. Patient has other active pulmonary disease such as predominant asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnoea. Allergic rhinitis is not exclusionary.
4. Lung surgery for volume reduction or lung transplantation: Patient has undergone lung volume reduction surgery, lobectomy, or bronchoscopic lung volume reduction (endobronchial blockers, airway bypass, endobronchial valves, thermal vapour ablation, biological sealants, massive pulmonary embolism and airway implants) within 1 year of Screening (Visit 1).
5. Patient is using nocturnal positive pressure (eg, continuous positive airway pressure or bi level positive airway pressure). Patient is using any non-invasive positive pressure ventilation device.
6. Patient who had 2 or more exacerbations of COPD (moderate or severe in intensity) within the last year prior to Screening (see Section 7.1 for definition of exacerbation of COPD).
7. Patient has been hospitalised due to poorly controlled COPD within 3 months of the Screening period.
8. Patient has acute worsening of COPD that requires treatment with corticosteroids or antibiotics in the 6 week interval prior to or during the Screening period.
9. Patient has had lower respiratory tract infection(s) that required antibiotics within 6 weeks prior to the Screening period.
10. Patient has significant cardiovascular disease that may be vulnerable to cardiovascular instability.
11. Patient with a QT interval corrected using Fridericia's formula (QTcF) value >450 ms for male and >470 ms for female or an ECG that is not suitable for QT measurements (eg, poorly defined termination of the T wave).
12. Patient with a heart rate <50 or >100 beats per minute (bpm).
13. Patient has clinically significant uncontrolled hypertension (>160 mmHg) as assessed by the Investigator.
14. Patient has seizures or a history of seizures requiring anticonvulsants within 12 months prior to Screening.
15. Patient is taking selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors whose dose has not been stable for at least 4 weeks prior to Screening, or exceeds the maximum recommended dose.
16. Patient has a symptomatic bladder neck obstruction, acute urinary retention or symptomatic non-stable prostate hypertrophy.
17. Any laboratory abnormality or suspicion of any clinically relevant disease or disorder (on history or examination), including uncontrolled diabetes or hypokalaemia (serum potassium <3.5 mmol/L), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient’s ability to participate in the
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method