Triple in Asthma Dose Finding
- Conditions
- Asthma
- Interventions
- Drug: CHF 5259 plus Foster 100/6 µgDrug: Foster 100/6 µg
- Registration Number
- NCT02127866
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 211
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF 5259 25 µg plus Foster 100/6 µg CHF 5259 plus Foster 100/6 µg - CHF 5259 50 µg plus Foster 100/6 µg CHF 5259 plus Foster 100/6 µg - CHF 5259 100 µg plus Foster 100/6 µg CHF 5259 plus Foster 100/6 µg - Foster 100/6 µg Foster 100/6 µg -
- Primary Outcome Measures
Name Time Method FEV1 AUC0-12h normalised by time on Day 42 Day 42
- Secondary Outcome Measures
Name Time Method Peak FEV1 on Day 42 Day 42 Adverse Events and Adverse Drug Reactions Up at Week 24 (study end)
Trial Locations
- Locations (44)
Chiesi Clinical Trial Site 0103
🇧🇬Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 0106
🇧🇬Sevlievo, Bulgaria
Chiesi Clinical Trial Site 0208
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 0401
🇮🇹Pisa, Italy
Chiesi Clinical Trial Site 0207
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 0107
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 0109
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 0101
🇧🇬Ruse, Bulgaria
Chiesi Clinical Trial Site 0303
🇭🇺Komárom, Hungary
Chiesi Clinical Trial Site 0502
🇵🇱Giżycko, Poland
Chiesi Clinical Trial Site 0504
🇵🇱Wrocław, Poland
Chiesi Clinical Trial Site 0408
🇮🇹Trieste, Italy
Chiesi Clinical Trial Site 0201
🇩🇪Leipzig, Germany
Chiesi Clinical Trial Site 0202
🇩🇪Magdeburg, Germany
Chiesi Clinical Trial Site 0102
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 0104
🇧🇬Troyan, Bulgaria
Chiesi Clinical Trial Site 0307
🇭🇺Balassagyarmat, Hungary
Chiesi Clinical Trial Site 0403
🇮🇹Brescia, Italy
Chiesi Clinical Trial Site 0404
🇮🇹Verona, Italy
Chiesi Clinical Trial Site 0203
🇩🇪Lubeck, Germany
Chiesi Clinical Trial Site 0302
🇭🇺Budapest, Hungary
Chiesi Clinical Trial Site 0304
🇭🇺Deszk, Hungary
Chiesi Clinical Trial Site 0306
🇭🇺Szarvas, Hungary
Chiesi Clinical Trial Site 0507
🇵🇱Gdańsk, Poland
Chiesi Clinical Trial Site 0503
🇵🇱Ostróda, Poland
Chiesi Clinical Trial Site 0508
🇵🇱Rzeszów, Poland
Chiesi Clinical Trial Site 0509
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 0601
🇬🇧Manchester, United Kingdom
Chiesi Clinical Trial Site 0110
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 0505
🇵🇱Łódź, Poland
Chiesi Clinical Trial Site 0301
🇭🇺Siófok, Hungary
Chiesi Clinical Trial Site 0506
🇵🇱Proszowice, Poland
Chiesi Clinical Trial Site 0204
🇩🇪Radebeul, Germany
Chiesi Clinical Trial Site 0105
🇧🇬Dupnitza, Bulgaria
Chiesi Clinical Trial Site 0108
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 0206
🇩🇪Grosshansdorf, Germany
Chiesi Clinical Trial Site 0305
🇭🇺Gödöllő, Hungary
Chiesi Clinical Trial Site 0210
🇩🇪Witten, Germany
Chiesi Clinical Trial Site 0402
🇮🇹Parma, Italy
Chiesi Clinical Trial Site 0510
🇵🇱Białystok, Poland
Chiesi Clinical Trial Site 0511
🇵🇱Kraków, Poland
Chiesi Clinical Trial Site 0512
🇵🇱Lublin, Poland
Chiesi Clinical Trial Site 0501
🇵🇱Oświęcim, Poland
Chiesi Clinical Trial Site 0602
🇬🇧London, United Kingdom