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
CARSAF
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
2 other identifiers
interventional
191
6 countries
6
Brief Summary
Cardiac Safety Study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2012
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 29, 2021
October 1, 2021
5 months
April 23, 2012
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Day 14 of study treatment
Secondary Outcomes (1)
Heart Rate and ECG parameters variation
Day 1 and Day 14 of Study Treatment
Study Arms (3)
CHF5993 HFA pMDI dose 1, BID
EXPERIMENTALCHF5993 HFA pMDI dose 1, BID
CHF5993 HFA pMDI dose 2, BID
EXPERIMENTALCHF5993 HFA pMDI dose 2, BID
CHF1535 HFA pMDI + Placebo
ACTIVE COMPARATORCHF1535 HFA pMDI BID plus placebo BID
Interventions
CHF1535 + CHF5992 dose 1 BID for 14 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital "Lozenets"
Sofia, 1407, Bulgaria
Praxis Dr. Kampschulte
Berlin, D-12165, Germany
Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő
Budapest, 1122, Hungary
ISPL Centrum Medyczne Robert M. Mróz
Bialystok, 15-003, Poland
State Budgetary Healthcare Institution of Moscow city
Moscow, 127018, Russia
Medicines Evaluation Unit, Langley Building
Manchester, M23 9QZ, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans-Jörg Kampschulte, MD
Arzt für Innere Medizin und Pneumologie, Berlin, Germany
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
April 23, 2012
First Posted
April 25, 2012
Study Start
April 1, 2012
Primary Completion
September 1, 2012
Study Completion
January 1, 2013
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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.