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Bronchodilator Properties and Safety in Asthma

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ClinicalTrials.gov Identifier: NCT01951222
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 17, 2014
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: V0162 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: V0162 dose1 Drug: V0162
Experimental: V0162 dose2 Drug: V0162
Placebo Comparator: placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Normalised AUC 0-24h of FEV1 at day 8 of treatment period [ Time Frame: At the 8th day of treatment period ]
    FEV1 assessed by spirometry


Secondary Outcome Measures :
  1. Parameters of the pulmonary function [ Time Frame: Day 1 and Day 8 of treatment period ]

    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.

  2. PEF [ Time Frame: Morning and evening from Day 1 to day 8 of treatment period ]
    PEF measured using a peak-flow meter

  3. Dyspnoea [ Time Frame: Day 1 to Day 8 of treatment period ]
    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.

  4. 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 ]
  5. 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 ]
  6. Holter-ECG [ Time Frame: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose ]
  7. Clinical laboratory tests (haematology, biochemistry, urinalysis) [ Time Frame: Visit 1 and Visit 11 ]
  8. AEs [ Time Frame: From Visit 1 to Visit 11 ]
  9. Normalised AUC 0-24h of FEV1 at Day 1 of treatment period [ Time Frame: The first day of treatment period ]
    FEV1 assessed by spirometry

  10. Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1 [ Time Frame: Difference between day 8 and first day of treatement period ]
    FEV1 assessed by spirometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951222


Locations
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Germany
CRO
Gauting, Germany
Sponsors and Collaborators
Pierre Fabre Medicament

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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT01951222    
Other Study ID Numbers: 2013-002517-35
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2013
Keywords provided by Pierre Fabre Medicament:
Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents