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Bronchodilator Properties and Safety in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

V0162

Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

V0162 dose1

V0162 dose2

placebo

Arm Description

Placebo

Outcomes

Primary Outcome Measures

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

FEV1 assessed by spirometry

Secondary Outcome Measures

Parameters of the pulmonary function

as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment periodadjusted for placebo effect: the normalised AUC0-9h of FEV1 (L), the normalised AUC0-12h of FEV1 (L), the peak of FEV1 (L) which is the higher observed post-dosing value, the trough of FEV1 (L) which is the last measurement before the next dosing (i.e. t24h), the normalised AUC0-9h,AUC0-12h, AUC0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75.

PEF

PEF measured using a peak-flow meter

Dyspnoea

The criteria will be the normalised AUC0-9h,AUC0-12h, and AUC0-24h of the dyspnoea measurements(mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period.

Vital signs

12-lead standard ECG

Holter-ECG

Clinical laboratory tests (haematology, biochemistry, urinalysis)

AEs

Normalised AUC 0-24h of FEV1 at Day 1 of treatment period

FEV1 assessed by spirometry

Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1

FEV1 assessed by spirometry

Full Information

NCT ID

NCT01951222

First Posted

September 5, 2013

Last Updated

September 16, 2014

Sponsor

Pierre Fabre Medicament

1. Study Identification

Unique Protocol Identification Number

NCT01951222

Brief Title

Bronchodilator Properties and Safety in Asthma

Official Title

Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pierre Fabre Medicament

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V0162 dose1

Arm Type

Experimental

Arm Title

V0162 dose2

Arm Type

Experimental

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

V0162

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Description

FEV1 assessed by spirometry

Time Frame

At the 8th day of treatment period

Secondary Outcome Measure Information:

Title

Parameters of the pulmonary function

Description

Time Frame

Day 1 and Day 8 of treatment period

Title

PEF

Description

PEF measured using a peak-flow meter

Time Frame

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

Title

Dyspnoea

Description

Time Frame

Day 1 to Day 8 of treatment period

Title

Vital signs

Time Frame

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

Title

12-lead standard ECG

Time Frame

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

Title

Holter-ECG

Time Frame

At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose

Title

Clinical laboratory tests (haematology, biochemistry, urinalysis)

Time Frame

Visit 1 and Visit 11

Title

AEs

Time Frame

From Visit 1 to Visit 11

Title

Normalised AUC 0-24h of FEV1 at Day 1 of treatment period

Description

FEV1 assessed by spirometry

Time Frame

The first day of treatment period

Title

Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1

Description

FEV1 assessed by spirometry

Time Frame

Difference between day 8 and first day of treatement period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

CRO

City

Gauting

Country

Germany

12. IPD Sharing Statement

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Bronchodilator Properties and Safety in Asthma

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