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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04636801




Registration number
NCT04636801
Ethics application status
Date submitted
16/11/2020
Date registered
19/11/2020
Date last updated
1/08/2024

Titles & IDs
Public title
A 52-week, Placebo-controlled Study to Evaluate the Efficacy and Safety of 2 Doses of CHF6001 DPI (Tanimilast), as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis (PILASTER)
Scientific title
A 52-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI add-on to Maintenance Triple Therapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Bronchitis
Secondary ID [1] 0 0
2020-003666-40
Secondary ID [2] 0 0
CLI-06001AA1-04
Universal Trial Number (UTN)
Trial acronym
PILASTER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Experimental: CHF6001 1600µg
Treatment: Drugs - Experimental: CHF6001 3200µg
Treatment: Drugs - Placebo

Experimental: CHF6001 1600µg -

Experimental: CHF6001 3200µg -

Placebo comparator: CHF6001 Placebo -


Treatment: Drugs: Experimental: CHF6001 1600µg
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).

Treatment: Drugs: Experimental: CHF6001 3200µg
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).

Treatment: Drugs: Placebo
CHF6001 matching placebo, 2 inhalations bid.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of moderate and severe COPD exacerbations occurring during the planned 52-week treatment period.
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [1] 0 0
The time to first moderate or severe exacerbation.
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
The annual rate of severe exacerbation.
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
The time to first severe exacerbation.
Timepoint [3] 0 0
Up to 52 weeks
Secondary outcome [4] 0 0
The number of on-treatment severe exacerbations.
Timepoint [4] 0 0
Up to 52 weeks
Secondary outcome [5] 0 0
Change from baseline (pre-dose visit 2) in pre-dose FEV1 at week 52.
Timepoint [5] 0 0
At Week 52
Secondary outcome [6] 0 0
Change from baseline in SGRQ total and domain scores at week 52.
Timepoint [6] 0 0
At week 52
Secondary outcome [7] 0 0
SGRQ response (change from baseline SGRQ total score = -4) at week 52.
Timepoint [7] 0 0
At week 52
Secondary outcome [8] 0 0
Change from baseline to last inter-visit period (week 40-52) in E-RS Total and subscale scores
Timepoint [8] 0 0
Up to 52 weeks
Secondary outcome [9] 0 0
E-RS response (change from baseline E-RS Total score = -2) at week 52.
Timepoint [9] 0 0
At week 52
Secondary outcome [10] 0 0
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)
Timepoint [10] 0 0
Up to 52 weeks
Secondary outcome [11] 0 0
Time to study medication discontinuation for any reason.
Timepoint [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
Up to 52 weeks

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with current asthma.
* Subjects with moderate or severe COPD exacerbation 4 weeks prior to study entry and randomization.
* Subjects with known a-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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/06/2025
Actual
Sample size
Target
3435
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Chiesi Clinical Trial - Site 36453 - Adelaide
Recruitment hospital [2] 0 0
Chiesi Clinical Trial - Site 36454 - Box Hill
Recruitment hospital [3] 0 0
Chiesi Clinical Trial - Site 36455 - Campbelltown
Recruitment hospital [4] 0 0
Chiesi Clinical Trial - Site 36456 - Clayton
Recruitment hospital [5] 0 0
Chiesi Clinical Trial - Site 36451 - South Brisbane
Recruitment hospital [6] 0 0
Chiesi Clinical Trial - Site 36452 - Westmead
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Box Hill
Recruitment postcode(s) [3] 0 0
- Campbelltown
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- South Brisbane
Recruitment postcode(s) [6] 0 0
- Westmead
Recruitment outside Australia
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United States of America
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Rochdale

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Chiesi Farmaceutici S.p.A.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04636801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Klaus F. Rabe, Prof.
Address 0 0
LungenClinic Grosshansdorf GmbH Wöhrendamm 80 22927 Großhansdorf GERMANY
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chiesi Clinical Trial info
Address 0 0
Country 0 0
Phone 0 0
+39 0521 2791
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04636801