A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD
Study Identifier:
CCD-06001AA1-01
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: CHF6001
- Drug: Budesonide
- Drug: Placebo
Date
Dec 2016 - Oct 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- COPD patients
- Non- childbearing potential or woman permanently sterilized or on one or more highly effective contraception
- Current/ex smokers (history \> 10 pack years)
- Post bronchodilatator FEV1 \>=30% and \<=70% predicted normal value and FEV1/FVC ratio \<0.7
- Documented history of at least 1 moderate or severe exacerbation in the 12 months prior to study entry
- Symptomatic patients (MMRC score ≥2 and a CAT score ≥10)
- Patients on daily maintenance therapy with an ICS/LABA .
Exclusion Criteria
- Diagnosis of asthma or other respiratory disorders
- Maintenance bronchodilators therapy only (eg LABA alone)
- Maintenance triple therapy.
- Occurrence of a moderate or severe COPD exacerbation within 6 weeks prior to study entry or during the run-in period.
- Patients requiring long term oxygen therapy.
- Concomitant or recent pulmonary rehabilitation programme
- Known respiratory disorders other than COPD
- Lung cancer or a history of lung cancer, active or history of cancer with less than 5 years disease free survival time
- Hypersensitivity to β2-agonist, corticosteroids, PDE4 inhibitors or any of the excipients
- Depression, generalised anxiety disorder, suicidal ideation
- Any clinically significant cardiovascular disease (IM, CHF III/IV; AF not controlled by therapy, etc) within 1 year of study entry
- Any relevant clinically significant cardiovascular condition, clinically abnormal significant 12-lead ECG (QTcF\>450 ms for male and \>470 for female) or clinically significant laboratory abnormalities
- Serum potassium value ≤3.5 mEq/L or \>5.5mEq/L and/or a fasting serum glucose value ≥140 mg/dL.
- History or symptoms of significant neurological disease
- Unstable concurrent disease: eg uncontrolled Thyroid disease or other endocrine diseases, gastrointestinal uncontrolled disease, uncontrolled immune diseases
- Renal impairment.
- Patients with abnormal alanine aminotransferase and/ or aspartate aminotransferase and/or bilirubin
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities and patients receiving treatment with any drug known to have a well defined potential for hepatotoxicity before Study entry
- Severely obese (BMI ≥35 kg/m2) or have experienced excessive weight loss recently
- History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening visit.
- Any recent participation to a clinical Study with other investigational drug
Healthy Volunteers
No
Protocol Summary
The purpose of this study is to evaluate the dose-response relationship of different doses of CHF6001 and to identify the optimal dose (s) in terms of benefit/risk ratio for further development in the target patient population.
Study Locations
No locations found.
Study Publications
Govoni M, Bassi M, Santoro D, Donegan S, Singh D. Serum IL-8 as a Determinant of Response to Phosphodiesterase-4 Inhibition in Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2023 Sep 1;208(5):559-569. doi: 10.1164/rccm.202301-0071OC.Singh D, Emirova A, Francisco C, Santoro D, Govoni M, Nandeuil MA. Efficacy and safety of CHF6001, a novel inhaled PDE4 inhibitor in COPD: the PIONEER study. Respir Res. 2020 Sep 22;21(1):246. doi: 10.1186/s12931-020-01512-y.