Clinical trial NCT02127866: Triple in Asthma Dose Finding
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma, anticholinergics
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: FEV1 AUC0-12h normalised by time on Day 42
timeFrame: Day 42
Secondary outcomes:
measure: Peak FEV1 on Day 42
timeFrame: Day 42
measure: Adverse Events and Adverse Drug Reactions
timeFrame: Up at Week 24 (study end)
Other outcomes:
Locations:
city: Dupnitza
country: Bulgaria
facility: Chiesi Clinical Trial Site 0105
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial Site 0101
city: Sevlievo
country: Bulgaria
facility: Chiesi Clinical Trial Site 0106
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0107
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0108
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0102
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0110
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0109
city: Stara Zagora
country: Bulgaria
facility: Chiesi Clinical Trial Site 0103
city: Troyan
country: Bulgaria
facility: Chiesi Clinical Trial Site 0104
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 0208
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 0207
city: Grosshansdorf
country: Germany
facility: Chiesi Clinical Trial Site 0206
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 0201
city: Lubeck
country: Germany
facility: Chiesi Clinical Trial Site 0203
city: Magdeburg
country: Germany
facility: Chiesi Clinical Trial Site 0202
city: Radebeul
country: Germany
facility: Chiesi Clinical Trial Site 0204
city: Witten
country: Germany
facility: Chiesi Clinical Trial Site 0210
city: Balassagyarmat
country: Hungary
facility: Chiesi Clinical Trial Site 0307
city: Budapest
country: Hungary
facility: Chiesi Clinical Trial Site 0302
city: Deszk
country: Hungary
facility: Chiesi Clinical Trial Site 0304
city: Gödöllő
country: Hungary
facility: Chiesi Clinical Trial Site 0305
city: Komárom
country: Hungary
facility: Chiesi Clinical Trial Site 0303
city: Siófok
country: Hungary
facility: Chiesi Clinical Trial Site 0301
city: Szarvas
country: Hungary
facility: Chiesi Clinical Trial Site 0306
city: Brescia
country: Italy
facility: Chiesi Clinical Trial Site 0403
city: Parma
country: Italy
facility: Chiesi Clinical Trial Site 0402
city: Pisa
country: Italy
facility: Chiesi Clinical Trial Site 0401
city: Trieste
country: Italy
facility: Chiesi Clinical Trial Site 0408
city: Verona
country: Italy
facility: Chiesi Clinical Trial Site 0404
city: Białystok
country: Poland
facility: Chiesi Clinical Trial Site 0510
city: Gdańsk
country: Poland
facility: Chiesi Clinical Trial Site 0507
city: Giżycko
country: Poland
facility: Chiesi Clinical Trial Site 0502
city: Kraków
country: Poland
facility: Chiesi Clinical Trial Site 0511
city: Lublin
country: Poland
facility: Chiesi Clinical Trial Site 0512
city: Ostróda
country: Poland
facility: Chiesi Clinical Trial Site 0503
city: Oświęcim
country: Poland
facility: Chiesi Clinical Trial Site 0501
city: Proszowice
country: Poland
facility: Chiesi Clinical Trial Site 0506
city: Rzeszów
country: Poland
facility: Chiesi Clinical Trial Site 0508
city: Wrocław
country: Poland
facility: Chiesi Clinical Trial Site 0504
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 0505
city: Łódź
country: Poland
facility: Chiesi Clinical Trial Site 0509
city: London
country: United Kingdom
facility: Chiesi Clinical Trial Site 0602
city: Manchester
country: United Kingdom
facility: Chiesi Clinical Trial Site 0601
Study officials:
affiliation: University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK
name: Dave Singh, MD
role: PRINCIPAL_INVESTIGATOR
References: