Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Chronic Bronchitis, PDE4 inhibitor, anti-inflammatory respiratory drug, Tanimilast
Brief summary
The purpose of the study is to evaluate the efficacy and safety of two doses of CHF6001 (Tanimilast), as add-on to maintenance triple therapy in the target patient population.
Interventions
DRUGExperimental: CHF6001 1600µg
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
DRUGExperimental: CHF6001 3200µg
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
DRUGPlacebo
CHF6001 matching placebo, 2 inhalations bid.
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥ 40 years with COPD and chronic bronchitis * Current or ex-smokers (history ≥ 10 pack years). * Post-bronchodilator FEV1 \<60% of the subject predicted normal value and FEV1/FVC ratio \< 0.7. * At least, one moderate or severe COPD exacerbation in previous year. * CAT score ≥ 10 * Subjects on regular maintenance triple therapy for at least 12 months prior to screening and receiving regular maintenance triple therapy for at least 3 months prior to screening visit
Exclusion criteria
* Subjects with current asthma. * Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization. * Subjects with known α-1 antitrypsin deficiency as the underlying cause of COPD. * Subjects with COPD emphysema or mixed phenotypes. * Subjects with known respiratory disorders other than COPD. * Subjects with active cancer or a history of lung cancer with full recovery less than 1 year after completing cancer therapy. * Subjects under Roflumilast treatment within 6 months before study entry. * Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation. * Subjects with clinically significant cardiovascular. * Subjects with a significant neurological disease. * Subjects with clinically significant laboratory abnormalities. * Subjects with moderate or severe hepatic impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period. | Up to 52 weeks | Moderate or severe exacerbation is defined by symptomatic worsening of COPD: * Moderate: requiring use of systemic corticosteroid (oral/IV/IM corticosteroids), and/or use of antibiotics * Severe: requiring hospitalisation or resulting in death |
Secondary
| Measure | Time frame |
|---|---|
| The annual rate of severe exacerbation. | Up to 52 weeks |
| The time to first severe exacerbation. | Up to 52 weeks |
| The number of on-treatment severe exacerbations. | Up to 52 weeks |
| Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52. | At Week 52 |
| Change from baseline in SGRQ total and domain scores at week 52. | At week 52 |
| The time to first moderate or severe exacerbation. | Up to 52 weeks |
| Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores | Up to 52 weeks |
| E-RS response (change from baseline E-RS Total score ≤ -2) at week 52. | At week 52 |
| Change from baseline to last inter-visit period (week 40-52) in the percentage of days without intake of rescue medication and in the average rescue medication use (number of puffs) | Up to 52 weeks |
| Time to study medication discontinuation for any reason. | Up to 52 weeks |
| Time to moderate or severe exacerbation or study medication discontinuation due to any adverse event, lack of efficacy or death (composite endpoint) and time to study medication discontinuation component. | Up to 52 weeks |
| SGRQ response (change from baseline SGRQ total score ≤ -4) at week 52. | At week 52 |
Countries
Albania, Argentina, Australia, Austria, Bosnia and Herzegovina, Bulgaria, Chile, China, Czechia, Georgia, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, North Macedonia, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Turkey (Türkiye), Ukraine, United Kingdom, United States
Outcome results
None listed