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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

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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Russian Federation
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Saint-Petersburg
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Saratov
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Russian Federation
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Humenné
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George
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South Africa
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Cordoba
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Madrid
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Pontevedra
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Spain
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Ivano-Frankivsk
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Ukraine
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Kherson
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Ukraine
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Kiev
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Ukraine
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Ukraine
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Ukraine
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Kyiv
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Ukraine
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Odessa
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Vinnytsya
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Ukraine
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Ukraine
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Zaporizhzhia
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Ukraine
State/province [277] 0 0
Zaporozhye
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United Kingdom
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Belfast
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United Kingdom
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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
Trial website
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
clinicaltrials_info@chiesi.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04636801