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NCT02127866 Clinical Trial

Triple in Asthma Dose Finding

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02127866
Other study ID # CCD-1206-PR-0088
Secondary ID 2013-003043-36
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2014
Est. completion date March 2015

Study information
Verified date April 2021
Source Chiesi Farmaceutici S.p.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 211
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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)
• 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)

Locations
Country Name City State
Bulgaria Chiesi Clinical Trial Site 0105 Dupnitza
Bulgaria Chiesi Clinical Trial Site 0101 Ruse
Bulgaria Chiesi Clinical Trial Site 0106 Sevlievo
Bulgaria Chiesi Clinical Trial Site 0102 Sofia
Bulgaria Chiesi Clinical Trial Site 0107 Sofia
Bulgaria Chiesi Clinical Trial Site 0108 Sofia
Bulgaria Chiesi Clinical Trial Site 0109 Sofia
Bulgaria Chiesi Clinical Trial Site 0110 Sofia
Bulgaria Chiesi Clinical Trial Site 0103 Stara Zagora
Bulgaria Chiesi Clinical Trial Site 0104 Troyan
Germany Chiesi Clinical Trial Site 0207 Berlin
Germany Chiesi Clinical Trial Site 0208 Berlin
Germany Chiesi Clinical Trial Site 0206 Grosshansdorf
Germany Chiesi Clinical Trial Site 0201 Leipzig
Germany Chiesi Clinical Trial Site 0203 Lubeck
Germany Chiesi Clinical Trial Site 0202 Magdeburg
Germany Chiesi Clinical Trial Site 0204 Radebeul
Germany Chiesi Clinical Trial Site 0210 Witten
Hungary Chiesi Clinical Trial Site 0307 Balassagyarmat
Hungary Chiesi Clinical Trial Site 0302 Budapest
Hungary Chiesi Clinical Trial Site 0304 Deszk
Hungary Chiesi Clinical Trial Site 0305 Gödöllo
Hungary Chiesi Clinical Trial Site 0303 Komárom
Hungary Chiesi Clinical Trial Site 0301 Siófok
Hungary Chiesi Clinical Trial Site 0306 Szarvas
Italy Chiesi Clinical Trial Site 0403 Brescia
Italy Chiesi Clinical Trial Site 0402 Parma
Italy Chiesi Clinical Trial Site 0401 Pisa
Italy Chiesi Clinical Trial Site 0408 Trieste
Italy Chiesi Clinical Trial Site 0404 Verona
Poland Chiesi Clinical Trial Site 0510 Bialystok
Poland Chiesi Clinical Trial Site 0507 Gdansk
Poland Chiesi Clinical Trial Site 0502 Gizycko
Poland Chiesi Clinical Trial Site 0511 Kraków
Poland Chiesi Clinical Trial Site 0505 Lódz
Poland Chiesi Clinical Trial Site 0509 Lódz
Poland Chiesi Clinical Trial Site 0512 Lublin
Poland Chiesi Clinical Trial Site 0503 Ostróda
Poland Chiesi Clinical Trial Site 0501 Oswiecim
Poland Chiesi Clinical Trial Site 0506 Proszowice
Poland Chiesi Clinical Trial Site 0508 Rzeszów
Poland Chiesi Clinical Trial Site 0504 Wroclaw
United Kingdom Chiesi Clinical Trial Site 0602 London
United Kingdom Chiesi Clinical Trial Site 0601 Manchester

Sponsors (1)
Lead Sponsor Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Bulgaria,  Germany,  Hungary,  Italy,  Poland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary FEV1 AUC0-12h normalised by time on Day 42 Day 42
Secondary Peak FEV1 on Day 42 Day 42
Secondary Adverse Events and Adverse Drug Reactions Up at Week 24 (study end)
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