Asthma MedDRA version: 16.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: V0162
Pharmaceutical Form: Capsule, hard
Current Sponsor code: V0162
Other descriptive name: D-MEQUITAZINE
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration num
Sponsors
Pierre Fabre Médicament/Institut de Recherche Pierre Fabre
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria (checked on Visit 1): -Male or female gender. -Aged 18 to 65 years-old. -18 = BMI =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Non-inclusion criteria (checked on Visit 1) Criteria related to pathologies -History of aspirin intolerance or aspirin-induced asthma. -History of life-threatening asthma within 5 years (i.e., brittle asthma or requiring hospitalisation in ICU). -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: mequitazine (and more generally all phenothiazine-derived compounds) and lactose. -Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, 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. -Abnormal vital signs (SBP > 140 or 90 or 100 or 100 or 220 or 120 ms, QTcF > 450 ms). -Congenital long QT syndrome, known or suspected prolongation of QT interval (QTcF > 450 ms), heart failure, hypokalemia, family history of Long QT syndrome, use of concomitant medications that prolong the QT/QTc interval. -Clinically relevant biological (haematology, biochemistry and urinary) exam abnormality, in particular hypokalemia. Criteria related to the population -Pregnancy or in post-partum period or nursing mother. -Alcohol abuse (more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1 glass of spirits = ½ pint of beer)). -Drug abuse. -Positive serology to HIV antibodies, HCV antibodies and/or HBs antigen. -Patients who cannot maintain regular day/night, waking/sleeping cycles (e.g. night shift workers). -Patients who are not able to understand the information (for linguistic or psychiatric reasons), in the judgement of the investigator. -Patients who had forfeited their freedom by administrative or legal decision, or who are under guardianship or wardship. -Patients who cannot be contacted by phone in an emergency. -Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Selection Visit (Visit 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the bronchodilator properties of V0162 inhalation powder delivered once daily during 8 days in adult patients with asthma usually treated with ICS and LABA.;Secondary Objective: To assess the effect on rescue medication use and the general and local safety of V0162 inhalation powder.;Primary end point(s): The main criterion will be the normalised AUC0-24h of FEV1 (L) assessed the last day of each treatment period. ;Timepoint(s) of evaluation of this end point: 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 22 h, 23 h, 24 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary criteria, for spirometry, will be •the normalised AUC 0-24h of FEV1 (L) assessed the first day of each treatment period, •the difference between the last and the first day of each treatment period in normalised AUC 0-24h of FEV1 (L) adjusted for placebo effect, 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 period adjusted for placebo effect: •the normalised AUC 0-9h of FEV1 (L), •the normalised AUC 0-12h 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 AUC 0-9h, AUC 0-12h, AUC 0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75. All the above spirometry criteria made of normalized AUCs will also be derived as baseline-adjusted normalised AUCs, baseline being defined as the predose measurement at the first day of each treatment period. The secondary criteria for PEF will be the mean of the daily morning measurements and the daily evening measurements from the first to the last day within each treatment period. The secondary criteria for dyspnoea measurements will be the normalised AUC 0-9h, AUC 0-12h, and AUC 0-24h 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. The secondary criteria for rescue medication use will be the number of puffs of rescue medication and the number of days without use during each treatment period. ;Timepoint(s) of evaluation of this end point: for more details, please refer to the protocol | — |
Countries
Germany
Contacts
Public ContactDr Lucilla MANSUY
Institut de Recherche Pierre Fabre-Pierre Fabre Innovation
Outcome results
None listed