Triple in Asthma Dose Finding (Triskel)

April 6, 2021 updated by: Chiesi Farmaceutici S.p.A.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Dupnitza, Bulgaria, 2600
        • Chiesi Clinical Trial Site 0105
      • Ruse, Bulgaria, 7002
        • Chiesi Clinical Trial Site 0101
      • Sevlievo, Bulgaria, 5400
        • Chiesi Clinical Trial Site 0106
      • Sofia, Bulgaria, 1233
        • Chiesi Clinical Trial Site 0107
      • Sofia, Bulgaria, 1336
        • Chiesi Clinical Trial Site 0108
      • Sofia, Bulgaria, 1407
        • Chiesi Clinical Trial Site 0102
      • Sofia, Bulgaria, 1431
        • Chiesi Clinical Trial Site 0110
      • Sofia, Bulgaria, 1432
        • Chiesi Clinical Trial Site 0109
      • Stara Zagora, Bulgaria, 6003
        • Chiesi Clinical Trial Site 0103
      • Troyan, Bulgaria, 5600
        • Chiesi Clinical Trial Site 0104
  • Germany
      • Berlin, Germany, 10787
        • Chiesi Clinical Trial Site 0208
      • Berlin, Germany, 12165
        • Chiesi Clinical Trial Site 0207
      • Grosshansdorf, Germany, 22927
        • Chiesi Clinical Trial Site 0206
      • Leipzig, Germany, 04357
        • Chiesi Clinical Trial Site 0201
      • Lubeck, Germany, 23552
        • Chiesi Clinical Trial Site 0203
      • Magdeburg, Germany, 39112
        • Chiesi Clinical Trial Site 0202
      • Radebeul, Germany, 01445
        • Chiesi Clinical Trial Site 0204
      • Witten, Germany, 58452
        • Chiesi Clinical Trial Site 0210
  • Hungary
      • Balassagyarmat, Hungary, 2660
        • Chiesi Clinical Trial Site 0307
      • Budapest, Hungary, 1122
        • Chiesi Clinical Trial Site 0302
      • Deszk, Hungary, 6772
        • Chiesi Clinical Trial Site 0304
      • Gödöllő, Hungary, 2100
        • Chiesi Clinical Trial Site 0305
      • Komárom, Hungary, 2900
        • Chiesi Clinical Trial Site 0303
      • Siófok, Hungary, 8600
        • Chiesi Clinical Trial Site 0301
      • Szarvas, Hungary, 5540
        • Chiesi Clinical Trial Site 0306
  • Italy
      • Brescia, Italy, 25123
        • Chiesi Clinical Trial Site 0403
      • Parma, Italy, 43125
        • Chiesi Clinical Trial Site 0402
      • Pisa, Italy, 56124
        • Chiesi Clinical Trial Site 0401
      • Trieste, Italy, 34149
        • Chiesi Clinical Trial Site 0408
      • Verona, Italy, 37134
        • Chiesi Clinical Trial Site 0404
  • Poland
      • Białystok, Poland, 15-430
        • Chiesi Clinical Trial Site 0510
      • Gdańsk, Poland, 80-847
        • Chiesi Clinical Trial Site 0507
      • Giżycko, Poland, 11-500
        • Chiesi Clinical Trial Site 0502
      • Kraków, Poland, 31-637
        • Chiesi Clinical Trial Site 0511
      • Lublin, Poland, 20-718
        • Chiesi Clinical Trial Site 0512
      • Ostróda, Poland, 14-100
        • Chiesi Clinical Trial Site 0503
      • Oświęcim, Poland, 32-600
        • Chiesi Clinical Trial Site 0501
      • Proszowice, Poland, 32-100
        • Chiesi Clinical Trial Site 0506
      • Rzeszów, Poland, 35-241
        • Chiesi Clinical Trial Site 0508
      • Wrocław, Poland, 51-162
        • Chiesi Clinical Trial Site 0504
      • Łódź, Poland, 90-141
        • Chiesi Clinical Trial Site 0505
      • Łódź, Poland, 90-153
        • Chiesi Clinical Trial Site 0509
  • United Kingdom
      • London, United Kingdom, W1G 8HU
        • Chiesi Clinical Trial Site 0602
      • Manchester, United Kingdom, M23 9QZ
        • Chiesi Clinical Trial Site 0601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHF 5259 25 µg plus Foster 100/6 µg
Drug: CHF 5259 plus Foster 100/6 µg
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)
Other Names:
  • glycopyrrolate + beclometasone/formoterol
Experimental: CHF 5259 50 µg plus Foster 100/6 µg
Drug: CHF 5259 plus Foster 100/6 µg
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)
Other Names:
  • glycopyrrolate + beclometasone/formoterol
Experimental: CHF 5259 100 µg plus Foster 100/6 µg
Drug: CHF 5259 plus Foster 100/6 µg
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)
Other Names:
  • glycopyrrolate + beclometasone/formoterol
Active Comparator: Foster 100/6 µg
Drug: Foster 100/6 µg

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)

Other Names:
  • beclometasone dipropionate/formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
FEV1 AUC0-12h normalised by time on Day 42
Time Frame: Day 42
Day 42

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak FEV1 on Day 42
Time Frame: Day 42
Day 42
Adverse Events and Adverse Drug Reactions
Time Frame: Up at Week 24 (study end)
Up at Week 24 (study end)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Dave SINGH, MD, University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Actual)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1206-PR-0088
  • 2013-003043-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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