Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Chiesi Farmaceutici S.p.A.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01730404
First received: August 23, 2012
Last updated: November 21, 2012
Last verified: November 2012
  Purpose

Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics (effect on biological markers of inflammation in induced sputum and in blood, and on pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of daily inhaled dosing.


Condition Intervention Phase
COPD
Drug: CHF6001 DPI
Drug: Roflumilast
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo and Active-controlled, Three-way Crossover Study to Evaluate the Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI (1200 µg Daily) in Subjects With COPD

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Adverse events, adverse drug reactions, serious adverse. [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: Yes ]
    The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.

  • Vital signs [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: Yes ]
  • 12-lead ECG parameters [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics of CHF 6001 and its metabolites [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: No ]
  • Induction of sputum [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: No ]
    Biomarkers of inflammation

  • Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: No ]
  • Lung function measurements [ Time Frame: After 28 days of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 65
Study Start Date: October 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF6001
CHF6001 DPI (Dry Powder Inhaler) once daily
Drug: CHF6001 DPI
Active Comparator: Roflumilast
Roflumilast, tablet, once daily
Drug: Roflumilast
Placebo Comparator: placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained prior to any study-related procedures.
  2. Male or female aged between 40 and 70 years inclusive.
  3. Current or past smoker of at least 10 pack/years
  4. BMI in the range of 18-35 Kg/m2
  5. GOLD Stage 2 and 3 COPD subjects
  6. A history of chronic bronchitis defined as chronic cough and sputum production
  7. At screening, subjects must be able to produce an adequate induced sputum sample
  8. Female subjects: post-menopausal women having at least 12 months of natural (spontaneous) amenorrhea, or women of childbearing potential using two acceptable methods of contraception for the duration of the study and for the following three months

Exclusion criteria:

  1. Female subjects: pregnant or lactating women
  2. Past or current history of asthma
  3. History of clinically significant hypotensive episodes
  4. History or symptoms of significant cardiovascular disease
  5. History or symptoms of significant neurological disease
  6. Unstable concurrent disease
  7. An abnormal and clinically significant 12-lead ECG
  8. Clinically relevant abnormal laboratory values
  9. Use of oral or systemic corticosteroids oral and/or nebulised Beta2 agonists and/or antibiotics within 6 weeks preceding the screening visit
  10. Moderate or severe hepatic impairment (Child-Pugh B or C)
  11. Intolerance/hypersensitivity or any contraindication to treatment with roflumilast, tiotropium bromide or salbutamol or any of the excipients contained in the formulations used in the study
  12. Chronic use of any other medication for treatment of lung disease like xanthines, antileukotrienes, systemic and inhaled corticosteroids, long acting beta2- agonists, roflumilast (other than the study drug) and cromoglycates
  13. Long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia.
  14. Having received an investigational medicinal drug within 30 days prior to study entry
  15. Blood draws of 250 mL or more within 45 days prior to enrolment into the study.
  16. Known respiratory disorders other than COPD.
  17. History of alcohol dependency, or substance abuse
  18. Inability to comply with the study Protocol for any other reason.
  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: NCT01730404

Contacts
Contact: Oriana Esposito, PhD +39 0521 1689204 O.Esposito@chiesi.com

Locations
Ireland
Celerion Not yet recruiting
Belfast, Ireland
United Kingdom
Parexel, early phases Not yet recruiting
Harrow, United Kingdom
Medicines Evaluation Unit Ltd Recruiting
Manchester, United Kingdom
Freeman Hospital Not yet recruiting
Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD MEU
Principal Investigator: Anthony DeSoyza, MD Freeman Hospital
Principal Investigator: Stephen Smith, MD Celerion
Principal Investigator: Tim Harrison, MD Nottingham University Hospitals NHS Trust
Principal Investigator: Muna Albayaty, MD Parexel, early phases
  More Information

No publications provided

Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01730404     History of Changes
Other Study ID Numbers: CCD-1201-PR-0079
Study First Received: August 23, 2012
Last Updated: November 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 31, 2014