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
NCT ID: NCT01584505
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
191 participants
INTERVENTIONAL
2012-04-30
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CHF5993 HFA pMDI dose 1, BID
CHF5993 HFA pMDI dose 1, BID
CHF1535 + CHF5992 dose 1 BID
CHF1535 + CHF5992 dose 1 BID for 14 days
CHF5993 HFA pMDI dose 2, BID
CHF5993 HFA pMDI dose 2, BID
CHF1535 + CHF5992 dose2 BID
CHF1535 + CHF5992 dose 2 BID for 14 days
CHF1535 HFA pMDI + Placebo
CHF1535 HFA pMDI BID plus placebo BID
CHF1535 daily dose
CHF1535 daily dose for 14 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CHF1535 + CHF5992 dose 1 BID
CHF1535 + CHF5992 dose 1 BID for 14 days
CHF1535 + CHF5992 dose2 BID
CHF1535 + CHF5992 dose 2 BID for 14 days
CHF1535 daily dose
CHF1535 daily dose for 14 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. Written informed consent obtained by the patient prior to any study related procedures
4. 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
Exclusion Criteria
* 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
2. Current diagnosis of asthma or other respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion
3. 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.
4. Patient with COPD who requires regular long term use of oxygen therapy
5. Patient who requires chronic mechanical ventilation for COPD
6. Patient treated regularly with oral or parenteral corticosteroids for their COPD
7. Change of COPD regular medication in the 4 weeks prior to enrollment
8. Unstable CV diseases
9. Known abnormality of any cardiac valve
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hans-Jörg Kampschulte, MD
Role: PRINCIPAL_INVESTIGATOR
Arzt für Innere Medizin und Pneumologie, Berlin, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital "Lozenets"
Sofia, , Bulgaria
Praxis Dr. Kampschulte
Berlin, , Germany
Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő
Budapest, , Hungary
ISPL Centrum Medyczne Robert M. Mróz
Bialystok, , Poland
State Budgetary Healthcare Institution of Moscow city
Moscow, , Russia
Medicines Evaluation Unit, Langley Building
Manchester, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Study Record on EU Clinical Trials Register including results
CSR Synopsis available in the CHIESI Clinical Study Register
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-004759-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-1107-PR-0067
Identifier Type: -
Identifier Source: org_study_id