Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04636801




Registration number
NCT04636801
Ethics application status
Date submitted
16/11/2020
Date registered
19/11/2020
Date last updated
3/10/2023

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
20/06/2025
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Albania
State/province [8] 0 0
Durres
Country [9] 0 0
Albania
State/province [9] 0 0
Elbasan
Country [10] 0 0
Albania
State/province [10] 0 0
Korca
Country [11] 0 0
Albania
State/province [11] 0 0
Tirana
Country [12] 0 0
Argentina
State/province [12] 0 0
Buenos Aires
Country [13] 0 0
Argentina
State/province [13] 0 0
Caba
Country [14] 0 0
Argentina
State/province [14] 0 0
Córdoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Florencio Varela
Country [16] 0 0
Argentina
State/province [16] 0 0
Florida
Country [17] 0 0
Argentina
State/province [17] 0 0
La Plata
Country [18] 0 0
Argentina
State/province [18] 0 0
Mar Del Plata
Country [19] 0 0
Argentina
State/province [19] 0 0
Mendoza
Country [20] 0 0
Argentina
State/province [20] 0 0
Monte Grande
Country [21] 0 0
Argentina
State/province [21] 0 0
Quilmes
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Argentina
State/province [23] 0 0
San Fernando
Country [24] 0 0
Argentina
State/province [24] 0 0
San Miguel De Tucumán
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel de Tucumán
Country [26] 0 0
Argentina
State/province [26] 0 0
Santa Fe
Country [27] 0 0
Austria
State/province [27] 0 0
Feldbach
Country [28] 0 0
Austria
State/province [28] 0 0
Grieskirchen
Country [29] 0 0
Austria
State/province [29] 0 0
Linz
Country [30] 0 0
Bosnia and Herzegovina
State/province [30] 0 0
Banja Luka
Country [31] 0 0
Bosnia and Herzegovina
State/province [31] 0 0
Doboj
Country [32] 0 0
Bosnia and Herzegovina
State/province [32] 0 0
Mostar
Country [33] 0 0
Bosnia and Herzegovina
State/province [33] 0 0
Pale
Country [34] 0 0
Bosnia and Herzegovina
State/province [34] 0 0
Sarajevo
Country [35] 0 0
Bosnia and Herzegovina
State/province [35] 0 0
Tesanj
Country [36] 0 0
Bosnia and Herzegovina
State/province [36] 0 0
Tuzla
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Blagoevgrad
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Dimitrovgrad
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Gabrovo
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Haskovo
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Kozloduy
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Lovech
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Montana
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Pernik
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Pleven
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Plovdiv
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Razgrad
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Ruse
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Sevlievo
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Sliven
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Sofia
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Stara Zagora
Country [53] 0 0
Bulgaria
State/province [53] 0 0
Veliko Tarnovo
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Vidin
Country [55] 0 0
Chile
State/province [55] 0 0
Concepcion
Country [56] 0 0
Chile
State/province [56] 0 0
Quillota
Country [57] 0 0
Chile
State/province [57] 0 0
Santiago
Country [58] 0 0
Chile
State/province [58] 0 0
Talca
Country [59] 0 0
Chile
State/province [59] 0 0
Valparaiso
Country [60] 0 0
China
State/province [60] 0 0
Baotou
Country [61] 0 0
China
State/province [61] 0 0
Beijing
Country [62] 0 0
China
State/province [62] 0 0
Changchun
Country [63] 0 0
China
State/province [63] 0 0
Changsha
Country [64] 0 0
China
State/province [64] 0 0
Chengdu
Country [65] 0 0
China
State/province [65] 0 0
Chongqing
Country [66] 0 0
China
State/province [66] 0 0
Guangzhou
Country [67] 0 0
China
State/province [67] 0 0
Haikou
Country [68] 0 0
China
State/province [68] 0 0
Hangzhou
Country [69] 0 0
China
State/province [69] 0 0
Harbin
Country [70] 0 0
China
State/province [70] 0 0
Hefei
Country [71] 0 0
China
State/province [71] 0 0
Hengyang
Country [72] 0 0
China
State/province [72] 0 0
Huanghou
Country [73] 0 0
China
State/province [73] 0 0
Huizhou
Country [74] 0 0
China
State/province [74] 0 0
Jinan
Country [75] 0 0
China
State/province [75] 0 0
Jinhua
Country [76] 0 0
China
State/province [76] 0 0
Liaoyang
Country [77] 0 0
China
State/province [77] 0 0
Nanchang
Country [78] 0 0
China
State/province [78] 0 0
Nanjing
Country [79] 0 0
China
State/province [79] 0 0
Pingxiang
Country [80] 0 0
China
State/province [80] 0 0
Qingyuan
Country [81] 0 0
China
State/province [81] 0 0
Shanghai
Country [82] 0 0
China
State/province [82] 0 0
Suzhou
Country [83] 0 0
China
State/province [83] 0 0
Taiyuan
Country [84] 0 0
China
State/province [84] 0 0
Taizhou
Country [85] 0 0
China
State/province [85] 0 0
Tianjin
Country [86] 0 0
China
State/province [86] 0 0
Wuhan
Country [87] 0 0
China
State/province [87] 0 0
Wuxi
Country [88] 0 0
China
State/province [88] 0 0
Xiangtan
Country [89] 0 0
China
State/province [89] 0 0
Xining
Country [90] 0 0
China
State/province [90] 0 0
Xinxiang
Country [91] 0 0
China
State/province [91] 0 0
Xuzhou
Country [92] 0 0
China
State/province [92] 0 0
Yanji
Country [93] 0 0
China
State/province [93] 0 0
Yiyang
Country [94] 0 0
China
State/province [94] 0 0
Zhanjiang
Country [95] 0 0
Czechia
State/province [95] 0 0
Brandys nad Labem
Country [96] 0 0
Czechia
State/province [96] 0 0
Havlickuv Brod
Country [97] 0 0
Czechia
State/province [97] 0 0
Jindrichuv Hradec
Country [98] 0 0
Czechia
State/province [98] 0 0
Lovosice
Country [99] 0 0
Czechia
State/province [99] 0 0
Mesice
Country [100] 0 0
Czechia
State/province [100] 0 0
Miroslav
Country [101] 0 0
Czechia
State/province [101] 0 0
Mlada Boleslav
Country [102] 0 0
Czechia
State/province [102] 0 0
Olomouc
Country [103] 0 0
Czechia
State/province [103] 0 0
Prague
Country [104] 0 0
Czechia
State/province [104] 0 0
Praha
Country [105] 0 0
Czechia
State/province [105] 0 0
Strakonice
Country [106] 0 0
Czechia
State/province [106] 0 0
Tabor
Country [107] 0 0
Czechia
State/province [107] 0 0
Varnsdorf
Country [108] 0 0
Georgia
State/province [108] 0 0
Tbilisi
Country [109] 0 0
Germany
State/province [109] 0 0
Bamberg
Country [110] 0 0
Germany
State/province [110] 0 0
Berlin
Country [111] 0 0
Germany
State/province [111] 0 0
Cottbus
Country [112] 0 0
Germany
State/province [112] 0 0
Darmstadt
Country [113] 0 0
Germany
State/province [113] 0 0
Delitzsch
Country [114] 0 0
Germany
State/province [114] 0 0
Essen
Country [115] 0 0
Germany
State/province [115] 0 0
Frankfurt
Country [116] 0 0
Germany
State/province [116] 0 0
Hamburg
Country [117] 0 0
Germany
State/province [117] 0 0
Hannover
Country [118] 0 0
Germany
State/province [118] 0 0
Koblenz
Country [119] 0 0
Germany
State/province [119] 0 0
Leipzig
Country [120] 0 0
Germany
State/province [120] 0 0
Mainz
Country [121] 0 0
Germany
State/province [121] 0 0
Munich
Country [122] 0 0
Germany
State/province [122] 0 0
Münster
Country [123] 0 0
Germany
State/province [123] 0 0
Peine
Country [124] 0 0
Germany
State/province [124] 0 0
Schleswig
Country [125] 0 0
Greece
State/province [125] 0 0
Athens
Country [126] 0 0
Greece
State/province [126] 0 0
Heraklion
Country [127] 0 0
Greece
State/province [127] 0 0
Ioannina
Country [128] 0 0
Greece
State/province [128] 0 0
Thessaloniki
Country [129] 0 0
Greece
State/province [129] 0 0
Volos
Country [130] 0 0
Hungary
State/province [130] 0 0
Balassagyarmat
Country [131] 0 0
Hungary
State/province [131] 0 0
Budapest
Country [132] 0 0
Hungary
State/province [132] 0 0
Csorna
Country [133] 0 0
Hungary
State/province [133] 0 0
Edelény
Country [134] 0 0
Hungary
State/province [134] 0 0
Godollo
Country [135] 0 0
Hungary
State/province [135] 0 0
Gyula
Country [136] 0 0
Hungary
State/province [136] 0 0
Monor
Country [137] 0 0
Hungary
State/province [137] 0 0
Nyíregyháza
Country [138] 0 0
Hungary
State/province [138] 0 0
Pécs
Country [139] 0 0
Hungary
State/province [139] 0 0
Sellye
Country [140] 0 0
Hungary
State/province [140] 0 0
Szeged
Country [141] 0 0
Hungary
State/province [141] 0 0
Szolnok
Country [142] 0 0
Hungary
State/province [142] 0 0
Szombathely
Country [143] 0 0
Hungary
State/province [143] 0 0
Százhalombatta
Country [144] 0 0
Hungary
State/province [144] 0 0
Tatabanya
Country [145] 0 0
Hungary
State/province [145] 0 0
Törökbálint
Country [146] 0 0
Israel
State/province [146] 0 0
Ashkelon
Country [147] 0 0
Israel
State/province [147] 0 0
Be'er Sheva
Country [148] 0 0
Israel
State/province [148] 0 0
Hadera
Country [149] 0 0
Israel
State/province [149] 0 0
Haifa
Country [150] 0 0
Israel
State/province [150] 0 0
Jerusalem
Country [151] 0 0
Israel
State/province [151] 0 0
Kfar Saba
Country [152] 0 0
Israel
State/province [152] 0 0
Petach Tikva
Country [153] 0 0
Israel
State/province [153] 0 0
Ramat Gan
Country [154] 0 0
Israel
State/province [154] 0 0
Tel HaShomer
Country [155] 0 0
Israel
State/province [155] 0 0
Tel-Aviv
Country [156] 0 0
Italy
State/province [156] 0 0
Brescia
Country [157] 0 0
Italy
State/province [157] 0 0
Catania
Country [158] 0 0
Italy
State/province [158] 0 0
Ferrara
Country [159] 0 0
Italy
State/province [159] 0 0
Roma
Country [160] 0 0
Italy
State/province [160] 0 0
Trieste
Country [161] 0 0
Mexico
State/province [161] 0 0
Chihuahua
Country [162] 0 0
Mexico
State/province [162] 0 0
Ciudad de Mexico
Country [163] 0 0
Mexico
State/province [163] 0 0
Cordoba
Country [164] 0 0
Mexico
State/province [164] 0 0
Durango
Country [165] 0 0
Mexico
State/province [165] 0 0
Guadalajara
Country [166] 0 0
Mexico
State/province [166] 0 0
Monterrey
Country [167] 0 0
Mexico
State/province [167] 0 0
Veracruz
Country [168] 0 0
Netherlands
State/province [168] 0 0
Almere
Country [169] 0 0
Netherlands
State/province [169] 0 0
Beek
Country [170] 0 0
Netherlands
State/province [170] 0 0
Breda
Country [171] 0 0
Netherlands
State/province [171] 0 0
Heerlen
Country [172] 0 0
Netherlands
State/province [172] 0 0
Leeuwarden
Country [173] 0 0
New Zealand
State/province [173] 0 0
Christchurch
Country [174] 0 0
New Zealand
State/province [174] 0 0
Hamilton
Country [175] 0 0
New Zealand
State/province [175] 0 0
Wellington
Country [176] 0 0
North Macedonia
State/province [176] 0 0
Gostivar
Country [177] 0 0
North Macedonia
State/province [177] 0 0
Prilep
Country [178] 0 0
North Macedonia
State/province [178] 0 0
Skopje
Country [179] 0 0
North Macedonia
State/province [179] 0 0
Tetovo
Country [180] 0 0
Poland
State/province [180] 0 0
Bialystok
Country [181] 0 0
Poland
State/province [181] 0 0
Gizycko
Country [182] 0 0
Poland
State/province [182] 0 0
Katowice
Country [183] 0 0
Poland
State/province [183] 0 0
Krakow
Country [184] 0 0
Poland
State/province [184] 0 0
Lodz
Country [185] 0 0
Poland
State/province [185] 0 0
Lublin
Country [186] 0 0
Poland
State/province [186] 0 0
Ostrowiec
Country [187] 0 0
Poland
State/province [187] 0 0
Piaseczno
Country [188] 0 0
Poland
State/province [188] 0 0
Poznan
Country [189] 0 0
Poland
State/province [189] 0 0
Sosnowiec
Country [190] 0 0
Poland
State/province [190] 0 0
Tarnow
Country [191] 0 0
Poland
State/province [191] 0 0
Torun
Country [192] 0 0
Poland
State/province [192] 0 0
Wroclaw
Country [193] 0 0
Poland
State/province [193] 0 0
Lódz
Country [194] 0 0
Romania
State/province [194] 0 0
Bacau
Country [195] 0 0
Romania
State/province [195] 0 0
Bragadiru
Country [196] 0 0
Romania
State/province [196] 0 0
Cluj-Napoca
Country [197] 0 0
Romania
State/province [197] 0 0
Cluj
Country [198] 0 0
Romania
State/province [198] 0 0
Constan?a
Country [199] 0 0
Romania
State/province [199] 0 0
Craiova
Country [200] 0 0
Romania
State/province [200] 0 0
Deva
Country [201] 0 0
Romania
State/province [201] 0 0
Iasi
Country [202] 0 0
Romania
State/province [202] 0 0
Oradea
Country [203] 0 0
Romania
State/province [203] 0 0
Resca
Country [204] 0 0
Romania
State/province [204] 0 0
Timisoara
Country [205] 0 0
Romania
State/province [205] 0 0
Timi?oara
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Chelyabinsk
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Kazan
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Kemerovo
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Moscow
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Moskva
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Nizhny Novgorod
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Odintsovskiy
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Rostov-na-Donu
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Rostov-on-Don
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Saint Petersburg
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Saint-Peterburg
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Saint-Petersburg
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Sankt-Peterburg
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Saratov
Country [220] 0 0
Russian Federation
State/province [220] 0 0
St. Petersburg
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Ulyanovsk
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Voronezh
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Yaroslavl'
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Yaroslavl
Country [225] 0 0
Serbia
State/province [225] 0 0
Belgrade
Country [226] 0 0
Serbia
State/province [226] 0 0
Kragujevac
Country [227] 0 0
Serbia
State/province [227] 0 0
Krusevac
Country [228] 0 0
Serbia
State/province [228] 0 0
Nis
Country [229] 0 0
Serbia
State/province [229] 0 0
Uzice
Country [230] 0 0
Slovakia
State/province [230] 0 0
Bardejov
Country [231] 0 0
Slovakia
State/province [231] 0 0
Humenné
Country [232] 0 0
Slovakia
State/province [232] 0 0
Košice
Country [233] 0 0
Slovakia
State/province [233] 0 0
Levice
Country [234] 0 0
Slovakia
State/province [234] 0 0
Spišská Nová Ves
Country [235] 0 0
South Africa
State/province [235] 0 0
Benoni
Country [236] 0 0
South Africa
State/province [236] 0 0
Bloemfontein
Country [237] 0 0
South Africa
State/province [237] 0 0
Centurion
Country [238] 0 0
South Africa
State/province [238] 0 0
Durban
Country [239] 0 0
South Africa
State/province [239] 0 0
George
Country [240] 0 0
South Africa
State/province [240] 0 0
Johannesburg
Country [241] 0 0
South Africa
State/province [241] 0 0
Pretoria
Country [242] 0 0
Spain
State/province [242] 0 0
Barakaldo
Country [243] 0 0
Spain
State/province [243] 0 0
Barcelona
Country [244] 0 0
Spain
State/province [244] 0 0
Barcelone
Country [245] 0 0
Spain
State/province [245] 0 0
Cordoba
Country [246] 0 0
Spain
State/province [246] 0 0
Madrid
Country [247] 0 0
Spain
State/province [247] 0 0
Palma De Mallorca
Country [248] 0 0
Spain
State/province [248] 0 0
Pontevedra
Country [249] 0 0
Spain
State/province [249] 0 0
Valencia
Country [250] 0 0
Spain
State/province [250] 0 0
Zaragoza
Country [251] 0 0
Turkey
State/province [251] 0 0
Adana
Country [252] 0 0
Turkey
State/province [252] 0 0
Bornova
Country [253] 0 0
Turkey
State/province [253] 0 0
Canakkale
Country [254] 0 0
Turkey
State/province [254] 0 0
Istanbul
Country [255] 0 0
Turkey
State/province [255] 0 0
Kocaeli
Country [256] 0 0
Turkey
State/province [256] 0 0
Mersin
Country [257] 0 0
Turkey
State/province [257] 0 0
Pamukkale
Country [258] 0 0
Turkey
State/province [258] 0 0
Yenisehir
Country [259] 0 0
Turkey
State/province [259] 0 0
Zeytinburnu
Country [260] 0 0
Ukraine
State/province [260] 0 0
Chernivtsi
Country [261] 0 0
Ukraine
State/province [261] 0 0
Dnepropetrovsk
Country [262] 0 0
Ukraine
State/province [262] 0 0
Dnipro
Country [263] 0 0
Ukraine
State/province [263] 0 0
Ivano-Frankivs'k
Country [264] 0 0
Ukraine
State/province [264] 0 0
Ivano-Frankivsk
Country [265] 0 0
Ukraine
State/province [265] 0 0
Kharkiv
Country [266] 0 0
Ukraine
State/province [266] 0 0
Kherson
Country [267] 0 0
Ukraine
State/province [267] 0 0
Kiev
Country [268] 0 0
Ukraine
State/province [268] 0 0
Kremenchuk
Country [269] 0 0
Ukraine
State/province [269] 0 0
Kryvyi Rih
Country [270] 0 0
Ukraine
State/province [270] 0 0
Kyiv
Country [271] 0 0
Ukraine
State/province [271] 0 0
Odessa
Country [272] 0 0
Ukraine
State/province [272] 0 0
Vinnytsia
Country [273] 0 0
Ukraine
State/province [273] 0 0
Vinnytsya
Country [274] 0 0
Ukraine
State/province [274] 0 0
Zaporizhya
Country [275] 0 0
Ukraine
State/province [275] 0 0
Zaporizhzhia
Country [276] 0 0
Ukraine
State/province [276] 0 0
Zaporozhye
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Belfast
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Bradford
Country [279] 0 0
United Kingdom
State/province [279] 0 0
London
Country [280] 0 0
United Kingdom
State/province [280] 0 0
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/ct2/show/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
+390521279715
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/NCT04636801