Bronchodilator Properties and Safety in Asthma

NCT01951222 | Completed Phase 2

• 1 other identifier: 2013-002517-35
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic

Outcome Measures

Primary Outcomes (1)

• Normalised AUC 0-24h of FEV1 at day 8 of treatment period

  FEV1 assessed by spirometry

  At the 8th day of treatment period

Secondary Outcomes (10)

• Parameters of the pulmonary function

  Day 1 and Day 8 of treatment period

• PEF

  Morning and evening from Day 1 to day 8 of treatment period

• Dyspnoea

  Day 1 to Day 8 of treatment period

• Vital signs

  Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11

• 12-lead standard ECG

  at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11

Study Arms (3)

V0162 dose1

EXPERIMENTAL

Drug: V0162

V0162 dose2

EXPERIMENTAL

Drug: V0162

placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

V0162 DRUG

V0162 dose1; V0162 dose2

Placebo OTHER

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years-old.
• ≤ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (1)

CRO

Gauting, Germany

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 26, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 17, 2014

Record last verified: 2013-09

Locations

DE (1)