EUCTR2013-002517-35-DE
Active, Not Recruiting
N/A
Bronchodilator properties and safety of a repeated dose of V0162 inhalation powder in asthma
Pierre Fabre Médicament/Institut de Recherche Pierre Fabre0 sitesJuly 2, 2013
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- Pierre Fabre Médicament/Institut de Recherche Pierre Fabre
- Status
- Active, Not Recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Inclusion criteria (checked on Visit 1\):
- •\-Male or female gender.
- •\-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:
- •Less than three of the following items present over the last week:
- •1\)daytime symptoms more than twice a week,
- •2\)any limitation of activities,
- •3\)any nocturnal symptoms/awakening,
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).
Outcomes
Primary Outcomes
Not specified
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