A 24-wk Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of a New PDE4 Inhibitor in Patients With COPD

NCT02986321 | Completed Phase 2

• 2 other identifiers: CCD-06001AA1-012015-005548-32
• Study Type: interventional
• Target: 1,130
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

anti-inflammatory respiratory drug; PDE4 inhibitor

Outcome Measures

Primary Outcomes (1)

• Change from baseline in predose morning FEV1 at 12 weeks

  overall effect of CHF6001 on change from baseline in predose morning FEV1

  week 12

Secondary Outcomes (8)

• Change from baseline in predose morning FEV1 at other timepoints

  weeks 3, 6, 18, 24

• Change from baseline in pre-dose morning IC

  weeks 3, 6, 12, 18, 24

• Change from baseline in pre-dose morning FVC

  weeks 3, 6, 12, 18, 24

• Change from baseline in TDI focal score

  weeks 3, 6, 12, 18, 24

• Change from baseline in SGRQ score

  weeks 3, 6, 12, 18, 24

Study Arms (6)

CHF6001 DOSE1

EXPERIMENTAL

DOSE1

Drug: CHF6001

CHF6001 DOSE2

EXPERIMENTAL

DOSE2

Drug: CHF6001

CHF6001 DOSE3

EXPERIMENTAL

DOSE3

Drug: CHF6001

CHF6001 DOSE4

EXPERIMENTAL

DOSE4

Drug: CHF6001

Matched placebo

PLACEBO COMPARATOR

placebo control

Drug: Placebo

Budesonide

ACTIVE COMPARATOR

Budesonide DPI 800µg

Drug: Budesonide

Interventions

CHF6001 DRUG

Dose response: Test one of 4 different doses of CHF6001

Also known as: Dose range finding

CHF6001 DOSE1; CHF6001 DOSE2; CHF6001 DOSE3; CHF6001 DOSE4

Budesonide DRUG

active control

Also known as: Active comparator

Budesonide

Placebo DRUG

placebo control

Matched placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Related Publications (2)

• 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.

  PMID: 37192443 DERIVED

• 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.

  PMID: 32962709 DERIVED

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tanimilast; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Dave Singh

  Medicines Evaluation Unit, Manchester, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2016
• First Posted: December 8, 2016
• Study Start: December 15, 2016
• Primary Completion: October 4, 2017
• Study Completion: January 9, 2018
• Last Updated: January 28, 2019

Record last verified: 2019-01