Clinical trial NCT02296411: Efficacy of LAMA Added to ICS in Treatment of Asthma
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled, 2-way Cross-over Study to Evaluate the Efficacy and Safety of CHF 5259 (Glycopyrrolate Bromide) pMDI on Top of QVAR® pMDI for the Treatment of Patients With Uncontrolled Asthma on Low-Medium Dose of Inhaled Corticosteroids
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: 2014-11-20
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 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 its safety.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: FEV1 (Forced Expiratory Volume in the first second) AUC0-12h (Area Under the Curve for 0-12 hours) normalised by time on Day 42
timeFrame: Day 42
Secondary outcomes:
measure: Peak FEV1 (Peak of Forced Expiratory Volume in the first second ) on Day 42
timeFrame: Day 42
Other outcomes:
measure: Adverse Events and Adverse Drug reactions
timeFrame: Up to 17 Weeks
Locations:
city: Ruse
country: Bulgaria
facility: Chiesi Clinical Trial Site 0107
city: Sevlievo
country: Bulgaria
facility: Chiesi Clinical Trial Site 0106
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0101
city: Sofia
country: Bulgaria
facility: Chiesi Clinical Trial Site 0109
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 0103
city: Berlin
country: Germany
facility: Chiesi Clinical Trial Site 0201
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 0203
city: Leipzig
country: Germany
facility: Chiesi Clinical Trial Site 0202
city: Magdeburg
country: Germany
facility: Chiesi Clinical Trial Site 0206
city: Radebeul
country: Germany
facility: Chiesi Clinical Trial Site 0207
city: Witten
country: Germany
facility: Chiesi Clinical Trial Site 0208
city: Brescia
country: Italy
facility: Chiesi Clinical Trial Site 0306
city: Pisa
country: Italy
facility: Chiesi Clinical Trial Site 0301
city: Pisa
country: Italy
facility: Chiesi Clinical Trial Site 0304
city: Pordenone
country: Italy
facility: Chiesi Clinical Trial Site 0303
city: Assen
country: Netherlands
facility: Chiesi Clinical Trial Site 0404
city: Helmond
country: Netherlands
facility: Chiesi Clinical Trial Site 0405
city: Bialystok
country: Poland
facility: Chiesi Clinical Trial Site 0501
city: Bialystok
country: Poland
facility: Chiesi Clinical Trial Site 0502
city: Elblag
country: Poland
facility: Chiesi Clinical Trial Site 0503
city: Krakow
country: Poland
facility: Chiesi Clinical Trial Site 0507
city: Krakow
country: Poland
facility: Chiesi Clinical Trial Site 0504
city: Lodz
country: Poland
facility: Chiesi Clinical Trial Site 0512
city: Lodz
country: Poland
facility: Chiesi Clinical Trial Site 0510
city: Wroclaw
country: Poland
facility: Chiesi Clinical Trial Site 0505
city: Zgierz
country: Poland
facility: Chiesi Clinical Trial Site 0506
Study officials:
References: