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

NCT01730404 | Completed Phase 2

• 1 other identifier: CCD-1201-PR-0079
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 5

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Pharmacokinetics of CHF 6001 and its metabolites

  After 28 days of treatment

• Induction of sputum

  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

Study Arms (3)

CHF6001

EXPERIMENTAL

CHF6001 DPI (Dry Powder Inhaler) once daily

Drug: CHF6001 DPI

Roflumilast

ACTIVE COMPARATOR

Roflumilast, tablet, once daily

Drug: Roflumilast

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

CHF6001 DPI DRUG

CHF6001

Roflumilast DRUG

Roflumilast

Placebo DRUG

placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-related procedures.
• Male or female aged between 40 and 70 years inclusive.
• Current or past smoker of at least 10 pack/years
• BMI in the range of 18-35 Kg/m2
• GOLD Stage 2 and 3 COPD subjects
• A history of chronic bronchitis defined as chronic cough and sputum production
• At screening, subjects must be able to produce an adequate induced sputum sample
• 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

You may not qualify if:

• Female subjects: pregnant or lactating women
• Past or current history of asthma
• History of clinically significant hypotensive episodes
• History or symptoms of significant cardiovascular disease
• History or symptoms of significant neurological disease
• Unstable concurrent disease
• An abnormal and clinically significant 12-lead ECG
• Clinically relevant abnormal laboratory values
• Use of oral or systemic corticosteroids oral and/or nebulised Beta2 agonists and/or antibiotics within 6 weeks preceding the screening visit
• Moderate or severe hepatic impairment (Child-Pugh B or C)
• 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
• 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
• Long term (at least 12 hours daily) use of oxygen therapy for chronic hypoxemia.
• Having received an investigational medicinal drug within 30 days prior to study entry
• Blood draws of 250 mL or more within 45 days prior to enrolment into the study.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (5)

Celerion

Belfast, Ireland

Location

Parexel, early phases

Harrow, United Kingdom

Location

Medicines Evaluation Unit Ltd

Manchester, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dave Singh, MD

  Medicines Evaluation Unit Ltd

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2012
• First Posted: November 21, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

IE (1); GB (4)