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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01730404
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Brief Summary:
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 or disease Intervention/treatment Phase
COPD Drug: CHF6001 DPI Drug: Roflumilast Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: CHF6001
CHF6001 DPI (Dry Powder Inhaler) once daily
Drug: CHF6001 DPI
Active Comparator: Roflumilast
Roflumilast, tablet, once daily
Drug: Roflumilast
Placebo Comparator: placebo
Drug: Placebo

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

  2. Vital signs [ Time Frame: After 28 days of treatment ]
  3. 12-lead ECG parameters [ Time Frame: After 28 days of treatment ]

Secondary Outcome Measures :
  1. Pharmacokinetics of CHF 6001 and its metabolites [ Time Frame: After 28 days of treatment ]
  2. Induction of sputum [ Time Frame: After 28 days of treatment ]
    Biomarkers of inflammation

  3. Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire [ Time Frame: After 28 days of treatment ]
  4. Lung function measurements [ Time Frame: After 28 days of treatment ]

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01730404

Belfast, Ireland
United Kingdom
Parexel, early phases
Harrow, United Kingdom
Medicines Evaluation Unit Ltd
Manchester, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Dave Singh, MD MEU
Principal Investigator: Anthony DeSoyza, MD Freeman Health System
Principal Investigator: Stephen Smith, MD Celerion
Principal Investigator: Tim Harrison, MD Nottingham University Hospitals NHS Trust
Principal Investigator: Muna Albayaty, MD Parexel, early phases

Additional Information:
Responsible Party: Chiesi Farmaceutici S.p.A. Identifier: NCT01730404     History of Changes
Other Study ID Numbers: CCD-1201-PR-0079
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017