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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04636814




Registration number
NCT04636814
Ethics application status
Date submitted
16/11/2020
Date registered
19/11/2020
Date last updated
18/04/2024

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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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 this study is to evaluate the efficacy and the safety of two doses of CHF6001
(Tanimilast) as add-on to maintenance triple therapy in the target patient population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04636814
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 279 715
Fax 0 0
Email 0 0
clinicaltrials_info@chiesi.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04636814