COPDPhase 2NCT01730404
Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
A Phase 2 study testing CHF6001 DPI and Roflumilast in people with COPD, run by Chiesi Farmaceutici S.p.A. at 5 sites in 2 countries.
Trial summary
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD
- What is being tested?
- CHF6001 DPI and Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2012to Oct 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study-related procedures.
- Male or female aged between 40 and 70 years inclusive.
- Current or past smoker of at least 10 pack/years
- BMI in the range of 18-35 Kg/m2
- GOLD Stage 2 and 3 COPD subjects
- A history of chronic bronchitis defined as chronic cough and sputum production
- At screening, subjects must be able to produce an adequate induced sputum sample
- Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential using two acceptable methods of contraception for the duration of the study and for the following three months
Who cannot join
- Female subjects: pregnant or lactating women
- Past or current history of asthma
- History of clinically significant hypotensive episodes
- History or symptoms of significant cardiovascular disease
- History or symptoms of significant neurological disease
- Unstable concurrent disease
Show all 18Show fewer
- An abnormal and clinically significant 12-lead ECG
- Clinically relevant abnormal laboratory values
- Use of oral or systemic corticosteroids oral and/or nebulised Beta2 agonists and/or antibiotics within 6 weeks preceding the screening visit
- Moderate or severe hepatic impairment (Child-Pugh B or C)
- Intolerance/hypersensitivity or any contraindication to treatment with roflumilast, tiotropium bromide or salbutamol or any of the excipients contained in the formulations used in the study
- Chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting beta2- agonists, roflumilast (other than the study drug) and cromoglycates
- Long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia.
- Having received an investigational medicinal drug within 30 days prior to study entry
- Blood draws of 250 mL or more within 45 days prior to enrolment into the study.
- Known respiratory disorders other than COPD.
- History of alcohol dependency, or substance abuse
- Inability to comply with the study Protocol for any other reason.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United Kingdom4 sites
Parexel, early phases
Harrow
Medicines Evaluation Unit Ltd
Manchester
Freeman Hospital
Newcastle
Nottingham University Hospitals NHS Trust
Nottingham
About this study
Official title: A Randomised, Double-blind, Double-dummy, Placebo and Active-controlled, Three-way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI (1200 µg Daily) in Subjects With COPD
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.
- Conditions
- COPD
- Being tested
- CHF6001 DPI, Roflumilast, Placebo
- 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.
CHF6001 DPIDrug
RoflumilastDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CHF6001 | Experimental | CHF6001 DPI (Dry Powder Inhaler) once daily Receives: Drug: CHF6001 DPI |
| Roflumilast | Active comparator | Roflumilast, tablet, once daily Receives: Drug: Roflumilast |
| placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, adverse drug reactions, serious adverse.
The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.
Measured: After 28 days of treatment
Vital signs
Measured: After 28 days of treatment
12-lead ECG parameters
Measured: After 28 days of treatment
Secondary outcomes (4)
Pharmacokinetics of CHF 6001 and its metabolites
Measured: After 28 days of treatment
Induction of sputum
Biomarkers of inflammation
Measured: After 28 days of treatment
Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire
Measured: After 28 days of treatment
Lung function measurements
Measured: After 28 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dave Singh, MD, Principal investigator, Medicines Evaluation Unit LtdAnthony DeSoyza, MD, Principal investigator, Freeman Health SystemStephen Smith, MD, Principal investigator, CelerionTim Harrison, MD, Principal investigator, Nottingham University Hospitals NHS TrustMuna Albayaty, MD, Principal investigator, Parexel, early phases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730404
- Sponsor's protocol ID
- CCD-1201-PR-0079
- Status last verified
- Mar 2017
- First submitted
- 23 Aug 2012
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double-dummy, Placebo and Active-controlled, Three-way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI (1200 µg Daily) in Subjects With COPD
- ClinicalTrials.gov ID
- NCT01730404
- Acronym / sponsor ID
- CCD-1201-PR-0079
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF6001 | Experimental | Drug: CHF6001 DPICHF6001 DPI (Dry Powder Inhaler) once daily |
| Roflumilast | Active comparator | Drug: RoflumilastRoflumilast, tablet, once daily |
| placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent obtained prior to any study-related procedures.
- Male or female aged between 40 and 70 years inclusive.
- Current or past smoker of at least 10 pack/years
- BMI in the range of 18-35 Kg/m2
- GOLD Stage 2 and 3 COPD subjects
Key exclusion criteria (18 listed)
- Female subjects: pregnant or lactating women
- Past or current history of asthma
- History of clinically significant hypotensive episodes
- History or symptoms of significant cardiovascular disease
- History or symptoms of significant neurological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHF6001 DPI | Drug | CHF6001 |
| Roflumilast | Drug | Roflumilast |
| Placebo | Drug | placebo |
Primary outcome
Adverse events, adverse drug reactions, serious adverse.
Time frame: After 28 days of treatment
The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.
Vital signs
Time frame: After 28 days of treatment
12-lead ECG parameters
Time frame: After 28 days of treatment
4 secondary outcomes
Pharmacokinetics of CHF 6001 and its metabolites
Time frame: After 28 days of treatment
Induction of sputum
Time frame: After 28 days of treatment
Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire
Time frame: After 28 days of treatment
Lung function measurements
Time frame: After 28 days of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Singh, MD principal investigator
Medicines Evaluation Unit Ltd
Anthony DeSoyza, MD principal investigator
Freeman Health System
Stephen Smith, MD principal investigator
Celerion
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF6001 DPI and Roflumilast in people with COPD, run by Chiesi Farmaceutici S.p.A. at 5 sites in 2 countries.
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 8 inclusion and 18 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Adverse events, adverse drug reactions, serious adverse. (time frame: After 28 days of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2017.