Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Phase 2CARSAFNCT01584505
Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD
A Phase 2 study testing CHF1535 + CHF5992 dose 1 BID, CHF1535 + CHF5992 dose2 BID and CHF1535 daily dose in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 6 sites in 6 countries.
Trial summary
Cardiac Safety Study Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- CHF1535 + CHF5992 dose 1 BID, CHF1535 + CHF5992 dose2 BID and CHF1535 daily dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 191 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Apr 2012to Jan 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults ≥ 40years and ≤ 80years old
- Male subjects: they and/or their partner must be willing to use an approved method of contraception 1) from the time of dose administration and until 30 days after the last dose of study. Subjects must not donate sperm for 30 days after the last dose of study drug
- Written informed consent obtained by the patient prior to any study related procedures
- Outpatient with diagnosis of COPD (defined in GOLD guidelines, up to date 2010) at least in the 6 months before the screening visit, including:
- Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)]/20; both current and ex smokers are eligible. For patients who are in smoking cessation therapy this must be completed at least 1 week before study enrollment
- Regular use of bronchodilators (e.g. β2-agonist or/and anticholinergics) in the previous 2 months at Visit 0
- Post-bronchodilator FEV1 ≥ 30% and ≤ 60% of the predicted normal value
- Post-bronchodilator FEV1/FVC ≤ 0.70
Who cannot join
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with already documented serum FSH level > 40mlU/mL or are using one of the following acceptable methods of contraception
- Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
- Hormonal contraception (implantable, patch, oral)
- Double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation
- Current diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion
- Hospitalization due to COPD exacerbation in the three months prior to screening and during run-in period or COPD exacerbation requiring systemic steroids and or antibiotics in the 6 weeks prior to screening and during run-in period. COPD exacerbation will be defined according to the following criteria: a sustained worsening of the patient condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication that includes prescription of oral corticosteroids and/or antibiotics, or need for hospitalization.
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- Patient with COPD who requires regular long term use of oxygen therapy
- Patient who requires chronic mechanical ventilation for COPD
- Patient treated regularly with oral or parenteral corticosteroids for their COPD
- Change of COPD regular medication in the 4 weeks prior to enrollment
- Unstable CV diseases
- Known abnormality of any cardiac valve
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Hungary1 site
Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő
Budapest, 1122
Russia1 site
State Budgetary Healthcare Institution of Moscow city
Moscow, 127018
United Kingdom1 site
Medicines Evaluation Unit, Langley Building
Manchester, M23 9QZ
About this study
Official title: Randomized, Double-Blind, Active Controlled, 3-Arm Parallel Group, Multi-National, Multi-Centre Study To Evaluate The Cardiac Safety Of Two Doses Of CHF5993 BID Delivered Via HFA PMDI Both Combined With CHF1535 BID Delivered Via HFA PMDI Versus CHF1535 BID Delivered Via HFA PMDI In Patients With Moderate To Severe COPD
Cardiac Safety Study
Read the detailed description
The purpose of this study is to demonstrate equivalence between CHF1535 plus CHF5992 (two different dosages) over CHF1535 alone in change from baseline in average 24-hour heart rate, as primary end point, and other ECG parameters.
- Being tested
- CHF1535 + CHF5992 dose 1 BID, CHF1535 + CHF5992 dose2 BID, CHF1535 daily dose
- Keywords
- COPD
- 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.
CHF1535 + CHF5992 dose 1 BIDDrug
CHF1535 + CHF5992 dose 1 BID for 14 days
CHF1535 + CHF5992 dose2 BIDDrug
CHF1535 + CHF5992 dose 2 BID for 14 days
CHF1535 daily doseDrug
CHF1535 daily dose for 14 days
| Study group | Role | What they receive |
|---|---|---|
| CHF5993 HFA pMDI dose 1, BID | Experimental | CHF5993 HFA pMDI dose 1, BID Receives: Drug: CHF1535 + CHF5992 dose 1 BID |
| CHF5993 HFA pMDI dose 2, BID | Experimental | CHF5993 HFA pMDI dose 2, BID Receives: Drug: CHF1535 + CHF5992 dose2 BID |
| CHF1535 HFA pMDI + Placebo | Active comparator | CHF1535 HFA pMDI BID plus placebo BID Receives: Drug: CHF1535 daily dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in average 24-hour heart rate at Final visit
To assess the effect on change from baseline in average 24h Heart Rate at Day 14 of study treatment
Measured: Day 14 of study treatment
Secondary outcomes (1)
Heart Rate and ECG parameters variation
Pre and post-dose
Measured: Day 1 and Day 14 of Study Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Jörg Kampschulte, MD, Principal investigator, Arzt für Innere Medizin und Pneumologie, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584505
- Sponsor's protocol ID
- CCD-1107-PR-0067
- Other IDs
- 2011-004759-37
- Acronym
- CARSAF
- Status last verified
- Oct 2021
- First submitted
- 23 Apr 2012
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Active Controlled, 3-Arm Parallel Group, Multi-National, Multi-Centre Study To Evaluate The Cardiac Safety Of Two Doses Of CHF5993 BID Delivered Via HFA PMDI Both Combined With CHF1535 BID Delivered Via HFA PMDI Versus CHF1535 BID Delivered Via HFA PMDI In Patients With Moderate To Severe COPD
- ClinicalTrials.gov ID
- NCT01584505
- Acronym / sponsor ID
- CARSAF / CCD-1107-PR-0067
- Keywords
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 Apr 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.
Cardiac Safety Study
Detailed description
The purpose of this study is to demonstrate equivalence between CHF1535 plus CHF5992 (two different dosages) over CHF1535 alone in change from baseline in average 24-hour heart rate, as primary end point, and other ECG parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CHF5993 HFA pMDI dose 1, BID | Experimental | Drug: CHF1535 + CHF5992 dose 1 BIDCHF5993 HFA pMDI dose 1, BID |
| CHF5993 HFA pMDI dose 2, BID | Experimental | Drug: CHF1535 + CHF5992 dose2 BIDCHF5993 HFA pMDI dose 2, BID |
| CHF1535 HFA pMDI + Placebo | Active comparator | Drug: CHF1535 daily doseCHF1535 HFA pMDI BID plus placebo BID |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female adults ≥ 40years and ≤ 80years old
- Male subjects: they and/or their partner must be willing to use an approved method of contraception 1) from the time of dose administration and until 30 days after the last dose of study. Subjects must not donate sperm for 30 days after the last dose of study drug
- Written informed consent obtained by the patient prior to any study related procedures
- Outpatient with diagnosis of COPD (defined in GOLD guidelines, up to date 2010) at least in the 6 months before the screening visit, including:
Key exclusion criteria (12 listed)
- Pregnant or lactating women or all women physiologically capable of becoming pregnant UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with already documented serum FSH level > 40mlU/mL or are using one of the following acceptable methods of contraception
- Current diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion
- Hospitalization due to COPD exacerbation in the three months prior to screening and during run-in period or COPD exacerbation requiring systemic steroids and or antibiotics in the 6 weeks prior to screening and during run-in period. COPD exacerbation will be defined according to the following criteria: a sustained worsening of the patient condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication that includes prescription of oral corticosteroids and/or antibiotics, or need for hospitalization.
- Patient with COPD who requires regular long term use of oxygen therapy
- Patient who requires chronic mechanical ventilation for COPD
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 |
|---|---|---|
| CHF1535 + CHF5992 dose 1 BIDCHF1535 + CHF5992 dose 1 BID for 14 days | Drug | CHF5993 HFA pMDI dose 1, BID |
| CHF1535 + CHF5992 dose2 BIDCHF1535 + CHF5992 dose 2 BID for 14 days | Drug | CHF5993 HFA pMDI dose 2, BID |
| CHF1535 daily doseCHF1535 daily dose for 14 days | Drug | CHF1535 HFA pMDI + Placebo |
Primary outcome
Change from baseline in average 24-hour heart rate at Final visit
Time frame: Day 14 of study treatment
To assess the effect on change from baseline in average 24h Heart Rate at Day 14 of study treatment
1 secondary outcome
Heart Rate and ECG parameters variation
Time frame: Day 1 and Day 14 of Study 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 Oct 2021.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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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.
Hans-Jörg Kampschulte, MD principal investigator
Arzt für Innere Medizin und Pneumologie, Berlin, Germany
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CHF1535 + CHF5992 dose 1 BID, CHF1535 + CHF5992 dose2 BID and CHF1535 daily dose in people with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD), run by Chiesi Farmaceutici S.p.A. at 6 sites in 6 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 12 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 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Bulgaria, Germany, Hungary, Poland, Russia and 1 more country. 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. 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 average 24-hour heart rate at Final visit (time frame: Day 14 of study treatment). 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 Oct 2021.