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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01584505
First received: April 23, 2012
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

Cardiac Safety Study


Condition Intervention Phase
Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Drug: CHF1535 + CHF5992 dose 1 BID
Drug: CHF1535 + CHF5992 dose2 BID
Drug: CHF1535 daily dose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Change from baseline in average 24-hour heart rate at Final visit [ Time Frame: Day 14 of study treatment ] [ Designated as safety issue: Yes ]
    To assess the effect on change from baseline in average 24h Heart Rate at Day 14 of study treatment


Secondary Outcome Measures:
  • Heart Rate and ECG parameters variation [ Time Frame: Day 1 and Day 14 of Study Treatment ] [ Designated as safety issue: Yes ]
    Pre and post-dose


Enrollment: 191
Study Start Date: April 2012
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF5993 HFA pMDI dose 1, BID
CHF5993 HFA pMDI dose 1, BID
Drug: CHF1535 + CHF5992 dose 1 BID
CHF1535 + CHF5992 dose 1 BID for 14 days
Experimental: CHF5993 HFA pMDI dose 2, BID
CHF5993 HFA pMDI dose 2, BID
Drug: CHF1535 + CHF5992 dose2 BID
CHF1535 + CHF5992 dose 2 BID for 14 days
Active Comparator: CHF1535 HFA pMDI + Placebo
CHF1535 HFA pMDI BID plus placebo BID
Drug: CHF1535 daily dose
CHF1535 daily dose for 14 days

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female adults ≥ 40years and ≤ 80years old
  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:

  1. 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
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584505

Locations
Bulgaria
Hospital "Lozenets"
Sofia, Bulgaria, 1407
Germany
Praxis Dr. Kampschulte
Berlin, Germany, D-12165
Hungary
Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő
Budapest, Hungary, 1122
Poland
ISPL Centrum Medyczne Robert M. Mróz
Białystok, Poland, 15-003
Russian Federation
State Budgetary Healthcare Institution of Moscow city
Moscow, Russian Federation, 127018
United Kingdom
Medicines Evaluation Unit, Langley Building
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Hans-Jörg Kampschulte, MD Arzt für Innere Medizin und Pneumologie, Berlin, Germany
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01584505     History of Changes
Other Study ID Numbers: CCD-1107-PR-0067, 2011-004759-37
Study First Received: April 23, 2012
Last Updated: October 13, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Bulgaria : National Centre of Public Health Protection (NCPHP)
Russia: Ministry of Health of the Russian Federation
Poland: Ministry of Health

Keywords provided by Chiesi Farmaceutici S.p.A.:
COPD

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014