Status:
COMPLETED
Efficacy of LAMA Added to ICS in Treatment of Asthma
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the superiority of the glycopyrrolate bromide (CHF 5259 pMDI) versus placebo on top of QVAR® pMDI, in terms of lung functions parameters, as well as to assess ...
Eligibility Criteria
Inclusion
- History of asthma ≥ 5 years and diagnosed before 40 years old
- Uncontrolled asthma on low-medium doses of Inhaled CorticoSteroid (ICS) with ACQ (Asthma Control Questionnaire) ≥1.5
- Pre-bronchodilator FEV1 ≥40% and \<90% of their predicted normal value
- Positive reversibility test
Exclusion
- Pregnant or lactating women
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
- Patients treated for asthma exacerbation 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02296411
Start Date
November 1 2014
End Date
August 1 2015
Last Update
April 8 2021
Active Locations (28)
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1
Chiesi Clinical Trial Site 0107
Rousse, Bulgaria, 7002
2
Chiesi Clinical Trial Site 0106
Sevlievo, Bulgaria, 5400
3
Chiesi Clinical Trial Site 0101
Sofia, Bulgaria, 1000
4
Chiesi Clinical Trial Site 0109
Sofia, Bulgaria, 1336