Bronchodilator Properties and Safety in Asthma

Pierre Fabre

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Other: Placebo; Drug: V0162

Study type: Interventional

Funder types: Industry

Identifiers

NCT01951222

2013-002517-35

Details and patient eligibility

About

Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.

V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 to 65 years-old.
• 18 ≤ BMI <30 kg/m².
• Clinical history consistent asthma, in the judgement of the investigator.
• Asthma controlled or partly controlled according to GINA 2012 criteria:
• Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
• Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
• Able to stop salbutamol at least 6 hours before a study visit.
• Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.

Exclusion criteria

• Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
• Upper or lower respiratory tract infection within 4 weeks.
• Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
• Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
• Intolerance to salbutamol.
• Intolerance to tiotropium (or any other atropine-derived compound).
• Intolerance to one of the ingredients of the study product
• Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
• Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
• Clinically relevant physical examination abnormality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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59 participants in 3 patient groups, including a placebo group

V0162 dose1

Experimental group

Treatment:

Drug: V0162

V0162 dose2

Experimental group

Treatment:

Drug: V0162

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo