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

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

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Placebo; Drug: Roflumilast; Drug: CHF6001 DPI

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Belfast, Ireland
    • Celerion
• United Kingdom
  • Harrow, United Kingdom
    • Parexel, early phases
  • Manchester, United Kingdom
    • Medicines Evaluation Unit Ltd
  • Newcastle, United Kingdom
    • Freeman Hospital
  • Nottingham, United Kingdom
    • Nottingham University Hospitals Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events, adverse drug reactions, serious adverse.	The number and percentage of subjects experiencing AEs, ADRs, serious AEs and AEs leading to study withdrawal.	After 28 days of treatment
Vital signs		After 28 days of treatment
12-lead ECG parameters		After 28 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of CHF 6001 and its metabolites		After 28 days of treatment
Induction of sputum	Biomarkers of inflammation	After 28 days of treatment
Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire		After 28 days of treatment
Lung function measurements		After 28 days of treatment

Collaborators and Investigators

• Sponsor: Chiesi Farmaceutici S.p.A.
• Investigators: Principal Investigator: Stephen Smith, MD, Celerion; Principal Investigator: Anthony DeSoyza, MD, Freeman Health System; Principal Investigator: Tim Harrison, MD, Nottingham University Hospitals Nhs Trust; Principal Investigator: Muna Albayaty, MD, Parexel, early phases

Publications and helpful links

Helpful Links

• Study Record on EU Clinical Trials Register including results

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: August 23, 2012
• First Submitted That Met QC Criteria: November 20, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Actual): March 29, 2017
• Last Update Submitted That Met QC Criteria: March 28, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CCD-1201-PR-0079