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

Study Identifier:
CCD-1107-PR-0067
ClinicalTrials.gov Identifier:
NCT01584505
EudraCT Identifier:
2011-004759-37
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Trial Documents

Clinical Study Report
Available Languages: English
Download document(s)

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: CHF1535 + CHF5992 dose 1 BID
  • Drug: CHF1535 + CHF5992 dose2 BID
  • Drug: CHF1535 daily dose
Date
Apr 2012 - Sep 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 80 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
Healthy Volunteers
No

Protocol Summary

Cardiac Safety Study

Study Locations

Location
Status
Location
Hospital "Lozenets"
Sofia, Bulgaria, 1407
Status
N/A
Location
Praxis Dr. Kampschulte
Berlin, Germany, D-12165
Status
N/A
Location
Fővárosi Önkormányzat Szent János Kórháza és Észak-budai Egyesített Kórházai Tüdőgondozó Szakrendelő
Budapest, Hungary, 1122
Status
N/A
Location
ISPL Centrum Medyczne Robert M. Mróz
Bialystok, Poland, 15-003
Status
N/A
Location
State Budgetary Healthcare Institution of Moscow city
Moscow, Russian Federation, 127018
Status
N/A
Location
Medicines Evaluation Unit, Langley Building
Manchester, United Kingdom, M23 9QZ
Status
N/A