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Triple in Asthma Dose Finding (Triskel)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CHF 5259 plus Foster 100/6 µg
Foster 100/6 µg
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, anticholinergics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female patients aged >=18 years
  • Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5
  • Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of COPD
  • Patients treated for asthma exacerbations in the 4 weeks prior to study entry
  • Patients who are in therapy for gastroesophageal reflux disease
  • Patients who have a clinically significant cardiovascular condition

Sites / Locations

  • Chiesi Clinical Trial Site 0105
  • Chiesi Clinical Trial Site 0101
  • Chiesi Clinical Trial Site 0106
  • Chiesi Clinical Trial Site 0107
  • Chiesi Clinical Trial Site 0108
  • Chiesi Clinical Trial Site 0102
  • Chiesi Clinical Trial Site 0110
  • Chiesi Clinical Trial Site 0109
  • Chiesi Clinical Trial Site 0103
  • Chiesi Clinical Trial Site 0104
  • Chiesi Clinical Trial Site 0208
  • Chiesi Clinical Trial Site 0207
  • Chiesi Clinical Trial Site 0206
  • Chiesi Clinical Trial Site 0201
  • Chiesi Clinical Trial Site 0203
  • Chiesi Clinical Trial Site 0202
  • Chiesi Clinical Trial Site 0204
  • Chiesi Clinical Trial Site 0210
  • Chiesi Clinical Trial Site 0307
  • Chiesi Clinical Trial Site 0302
  • Chiesi Clinical Trial Site 0304
  • Chiesi Clinical Trial Site 0305
  • Chiesi Clinical Trial Site 0303
  • Chiesi Clinical Trial Site 0301
  • Chiesi Clinical Trial Site 0306
  • Chiesi Clinical Trial Site 0403
  • Chiesi Clinical Trial Site 0402
  • Chiesi Clinical Trial Site 0401
  • Chiesi Clinical Trial Site 0408
  • Chiesi Clinical Trial Site 0404
  • Chiesi Clinical Trial Site 0510
  • Chiesi Clinical Trial Site 0507
  • Chiesi Clinical Trial Site 0502
  • Chiesi Clinical Trial Site 0511
  • Chiesi Clinical Trial Site 0512
  • Chiesi Clinical Trial Site 0503
  • Chiesi Clinical Trial Site 0501
  • Chiesi Clinical Trial Site 0506
  • Chiesi Clinical Trial Site 0508
  • Chiesi Clinical Trial Site 0504
  • Chiesi Clinical Trial Site 0505
  • Chiesi Clinical Trial Site 0509
  • Chiesi Clinical Trial Site 0602
  • Chiesi Clinical Trial Site 0601

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

CHF 5259 25 µg plus Foster 100/6 µg

CHF 5259 50 µg plus Foster 100/6 µg

CHF 5259 100 µg plus Foster 100/6 µg

Foster 100/6 µg

Arm Description

Outcomes

Primary Outcome Measures

FEV1 AUC0-12h normalised by time on Day 42

Secondary Outcome Measures

Peak FEV1 on Day 42
Adverse Events and Adverse Drug Reactions

Full Information

First Posted
April 9, 2014
Last Updated
April 6, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02127866
Brief Title
Triple in Asthma Dose Finding
Acronym
Triskel
Official Title
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER® 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA UNDER MEDIUM DOSES OF INHALED CORTICOSTEROIDS PLUS LONG-ACTING β2-AGONISTS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the optimal dose of CHF 5259 (glycopyrrolate bromide) on top of Foster which provides the optimal additive bronchodilator effect to asthmatic patients whose symptoms are uncontrolled with medium dose of inhaled corticosteroids plus long acting beta2 agonists.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, anticholinergics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5259 25 µg plus Foster 100/6 µg
Arm Type
Experimental
Arm Title
CHF 5259 50 µg plus Foster 100/6 µg
Arm Type
Experimental
Arm Title
CHF 5259 100 µg plus Foster 100/6 µg
Arm Type
Experimental
Arm Title
Foster 100/6 µg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
CHF 5259 plus Foster 100/6 µg
Other Intervention Name(s)
glycopyrrolate + beclometasone/formoterol
Intervention Description
Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Intervention Type
Drug
Intervention Name(s)
Foster 100/6 µg
Other Intervention Name(s)
beclometasone dipropionate/formoterol
Intervention Description
Active comparator Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
Primary Outcome Measure Information:
Title
FEV1 AUC0-12h normalised by time on Day 42
Time Frame
Day 42
Secondary Outcome Measure Information:
Title
Peak FEV1 on Day 42
Time Frame
Day 42
Title
Adverse Events and Adverse Drug Reactions
Time Frame
Up at Week 24 (study end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged >=18 years Uncontrolled asthma on medium doses of ICS+LABA with ACQ >=1.5 Pre-bronchodilator FEV1 ≥40% and <80% of their predicted normal value Exclusion Criteria: Pregnant or lactating women Diagnosis of COPD Patients treated for asthma exacerbations in the 4 weeks prior to study entry Patients who are in therapy for gastroesophageal reflux disease Patients who have a clinically significant cardiovascular condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Singh, MD
Organizational Affiliation
University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi Clinical Trial Site 0105
City
Dupnitza
ZIP/Postal Code
2600
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0101
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0106
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0107
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0108
City
Sofia
ZIP/Postal Code
1336
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0102
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0110
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0109
City
Sofia
ZIP/Postal Code
1432
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0103
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0104
City
Troyan
ZIP/Postal Code
5600
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 0208
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0207
City
Berlin
ZIP/Postal Code
12165
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0206
City
Grosshansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0201
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0203
City
Lubeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0202
City
Magdeburg
ZIP/Postal Code
39112
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0204
City
Radebeul
ZIP/Postal Code
01445
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0210
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Chiesi Clinical Trial Site 0307
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0302
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0304
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0305
City
Gödöllő
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0303
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0301
City
Siófok
ZIP/Postal Code
8600
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0306
City
Szarvas
ZIP/Postal Code
5540
Country
Hungary
Facility Name
Chiesi Clinical Trial Site 0403
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0402
City
Parma
ZIP/Postal Code
43125
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0401
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0408
City
Trieste
ZIP/Postal Code
34149
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0404
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Chiesi Clinical Trial Site 0510
City
Białystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0507
City
Gdańsk
ZIP/Postal Code
80-847
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0502
City
Giżycko
ZIP/Postal Code
11-500
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0511
City
Kraków
ZIP/Postal Code
31-637
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0512
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0503
City
Ostróda
ZIP/Postal Code
14-100
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0501
City
Oświęcim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0506
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0508
City
Rzeszów
ZIP/Postal Code
35-241
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0504
City
Wrocław
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0505
City
Łódź
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0509
City
Łódź
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Chiesi Clinical Trial Site 0602
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
Facility Name
Chiesi Clinical Trial Site 0601
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information. Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing Access Criteria
Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-003043-36
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

Triple in Asthma Dose Finding

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