AzTrials
AzTrials

Chronic Obstructive Pulmonary DiseasePhase 2PIONEERNCT02986321

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

A Phase 2 study testing CHF6001 and Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A..

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 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
CHF6001 and Budesonide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,130 participants
Where
No sites listed yet
Study dates
15 Dec 2016to 9 Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 .

Who cannot join

  • 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
Show all 21Show fewer
  • 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

About this study

Official title: A 24-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled, Parallel Group, Dose Ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF6001 DPI in Patients With COPD on a Background Therapy

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.

Read the detailed description

This is a phase II, randomized, double-blind, double-dummy, placebo and active controlled multinational, multicenter, dose ranging, 6-arm parallel-group study to identify the optimal dose of CHF6001, PDE4 inhibitor under development, with respect to lung functions and symptoms.

After a 2-wk run-in period under formoterol (Oxis Turbohaler®) and rescue salbutamol prn, patients will be randomized to one of the 6 treatment groups. After the randomization, patients will be assessed after 3, 6, 12, 18 and 24 weeks of treatment at clinic/hospital. A follow-up visit will be performed 12 days after the last visit.

During the study, patients will report daily symptoms with the EXACT-PRO/E-RS questionnaire, rescue/background medication use and compliance with the study medications. AEs, SAEs and COPD exacerbations will be monitored throughout the study. At randomization and subsequent visits, patients will undergo physical and vital signs examinations, spirometry measurement, 12-lead ECG. Symptoms and Health status will be assessed through validated questionnaires. Routine lab analysis and blood biomarkers will be done.

Being tested
CHF6001, Budesonide, Placebo
Keywords
anti-inflammatory respiratory drug, PDE4 inhibitor
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.

  • CHF6001Drug

    Also called Dose range finding

    Dose response: Test one of 4 different doses of CHF6001

  • BudesonideDrug

    Also called Active comparator

    active control

  • PlaceboDrug

    placebo control

Study groups in NCT02986321
Study groupRoleWhat they receive
CHF6001 DOSE1ExperimentalDOSE1
Receives: Drug: CHF6001
CHF6001 DOSE2ExperimentalDOSE2
Receives: Drug: CHF6001
CHF6001 DOSE3ExperimentalDOSE3
Receives: Drug: CHF6001
CHF6001 DOSE4ExperimentalDOSE4
Receives: Drug: CHF6001
Matched placeboPlacebo comparatorplacebo control
Receives: Drug: Placebo
BudesonideActive comparatorBudesonide DPI 800µg
Receives: Drug: Budesonide

What is being measured

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

  1. Change from baseline in predose morning FEV1 at 12 weeks

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

    Measured: week 12

Secondary outcomes (8)

  1. Change from baseline in predose morning FEV1 at other timepoints

    Change from Baseline

    Measured: weeks 3, 6, 18, 24

  2. Change from baseline in pre-dose morning IC

    Change from Baseline for other lung function parameters

    Measured: weeks 3, 6, 12, 18, 24

  3. Change from baseline in pre-dose morning FVC

    Change from Baseline for other lung function parameters

    Measured: weeks 3, 6, 12, 18, 24

  4. Change from baseline in TDI focal score

    Change of TDI score

    Measured: weeks 3, 6, 12, 18, 24

  5. Change from baseline in SGRQ score

    Change of SGRQ score

    Measured: weeks 3, 6, 12, 18, 24

  6. Change from baseline in E-RS score

    Change of E-RSI score

    Measured: weeks 3, 6, 12, 18, 24

  7. COPD exacerbation rate over 24 weeks of treatment

    exacerbation rate

    Measured: 24 weeks

  8. Time to first COPD exacerbation

    Time to first COPD exacerbation

    Measured: 24 weeks

Timeline

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

  1. First posted8 Dec 2016 (estimated)
  2. Study start15 Dec 2016
  3. Primary completion4 Oct 2017
  4. Study completion9 Jan 2018

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02986321
Sponsor's protocol ID
CCD-06001AA1-01
Other IDs
2015-005548-32, 2015
Acronym
PIONEER
Status last verified
Jan 2019
First submitted
24 Nov 2016
Last updated
28 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 37192443

  • 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.

    PubMed 32962709

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CHF6001 and Budesonide in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A..

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 21 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 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline in predose morning FEV1 at 12 weeks (time frame: week 12). 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 NCT02986321, which also lists 2 linked publications.

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 28 Jan 2019.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
PIONEER Clinical Trial NCT02986321 | AzTrials