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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730404
• Other study ID #: CCD-1201-PR-0079
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2012
• Last updated: March 28, 2017
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

Drug:
• CHF6001 DPI

• Roflumilast

• Placebo

Locations

Country	Name	City	State
Ireland	Celerion	Belfast
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

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Vital signs		After 28 days of treatment
Primary	12-lead ECG parameters		After 28 days of treatment
Secondary	Pharmacokinetics of CHF 6001 and its metabolites		After 28 days of treatment
Secondary	Induction of sputum	Biomarkers of inflammation	After 28 days of treatment
Secondary	Baseline Dyspnea Index and Transition Dyspnea Index Questionnaire		After 28 days of treatment
Secondary	Lung function measurements		After 28 days of treatment

External Links

•   Study Record on EU Clinical Trials Register including results