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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04636814




Registration number
NCT04636814
Ethics application status
Date submitted
16/11/2020
Date registered
19/11/2020

Titles & IDs
Public title
A 52-week, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and Safety of Two Doses of CHF6001 DPI (Tanimilast) as add-on to Maintenance Triple Therapy in Subjects With COPD and Chronic Bronchitis. (PILLAR)
Scientific title
A 52-week, Randomized, Double-blind, Double-dummy, Placebo- and Active- Controlled (Roflumilast, Daliresp® 500µg), 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
2020-003648-97
Secondary ID [2] 0 0
CLI-06001AA1-05
Universal Trial Number (UTN)
Trial acronym
PILLAR
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 - CHF6001 1600µg
Treatment: Drugs - CHF6001 3200µg
Treatment: Drugs - Placebo
Treatment: Drugs - Roflumilast

Experimental: CHF6001 1600µg -

Experimental: CHF6001 3200µg -

Placebo comparator: Placebo -

Active comparator: Roflumilast -


Treatment: Drugs: CHF6001 1600µg
CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily

Treatment: Drugs: CHF6001 3200µg
CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily

Treatment: Drugs: Placebo
CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily

Treatment: Drugs: Roflumilast
- 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and 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 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 exacerbations.
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 all on-treatment severe exacerbations.
Timepoint [4] 0 0
Up to 52 weeks
Secondary outcome [5] 0 0
The number of all on-treatment exacerbations requiring systemic corticosteroids.
Timepoint [5] 0 0
Up to 52 weeks
Secondary outcome [6] 0 0
Change from baseline (pre-dose Visit 2) in pre-dose FEV1, at week 52.
Timepoint [6] 0 0
At week 52
Secondary outcome [7] 0 0
Change from baseline in Saint Georges Respiratory Questionnaire (SGRQ) total and domain scores at week 52.
Timepoint [7] 0 0
At week 52
Secondary outcome [8] 0 0
Saint Georges Respiratory Questionnaire response (SGRQ) (change from baseline SGRQ total score = -4) at week 52.
Timepoint [8] 0 0
At week 52
Secondary outcome [9] 0 0
Change from baseline to last inter-visit period (week 40-52) in EXACT-Respiratory Symptoms (E-RS) Total and subscale scores.
Timepoint [9] 0 0
Up to 52 weeks
Secondary outcome [10] 0 0
E-RS response (change from baseline E-RS Total score = -2) at week 52.
Timepoint [10] 0 0
At week 52
Secondary outcome [11] 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 [11] 0 0
Up to 52 weeks
Secondary outcome [12] 0 0
Time to study medication discontinuation for any reason.
Timepoint [12] 0 0
Up to 52 weeks
Secondary outcome [13] 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 [13] 0 0
Up to 52 weeks
Secondary outcome [14] 0 0
Time to first moderate/severe exacerbation or study medication discontinuation due to any class-related AE, lack of efficacy, or death (composite endpoint) and time to study medication discontinuation component.
Timepoint [14] 0 0
Up to 52 weeks
Secondary outcome [15] 0 0
Key Secondary Variable: Change from baseline in SGRQ Total score at week 52
Timepoint [15] 0 0
At week 52

Eligibility
Key inclusion criteria
* Adults aged = 40 years, with COPD and with chronic bronchitis.
* Current smokers or ex-smokers (history of =10 pack years).
* Post-bronchodilator FEV1 <50% of the patient predicted normal value and FEV1/FVC ratio < 0.7.
* At least, one moderate or severe COPD exacerbation in the 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 before study entry and randomisation
* Subjects with known a-1 antitrypsin deficiency as the underlying cause of COPD.
* Subjects with primary diagnosis of emphysema not related to COPD.
* Subjects with known respiratory disorders other than COPD.
* Subjects with lung volume reduction surgery.
* Subjects with active cancer or a history of lung cancer.
* 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 condition.
* Subjects with 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
12/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
18/09/2027
Actual
Sample size
Target
3980
Accrual to date
Final
Recruitment in Australia
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Bardejov
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Ukraine
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Kharkiv
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Kharkov
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Kiev
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Poltava
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Vinnytsia
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Zaporizhia
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United Kingdom
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Belfast
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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
Fernando J. MARTINEZ, Prof.
Address 0 0
Weill Cornell Medical College, New York Presbyterian Hospital, 1305 York avenue box 96 NY 10021 USA
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/NCT04636814