EUCTR2016-000472-22-SK
Active, not recruiting
Phase 1
A multi-center, randomized, 12-week treatment, double blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma - n/a
ConditionsAsthmaMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
DrugsAsmanex Twisthaler
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 802
- Status
- Active, not recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Patients with a documented diagnosis of asthma for a period of at least
- •3 months prior to Screening Visit
- •\- Patients who have used low dose ICS , with or without controller (ie,
- •LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1
- •month prior to Screening Visit
- •\-Adult patients who are symptomatic despite treatment with existing
- •Patients with ACQ\-7 score \= 1\.5 at Visit 101 and at Visit 102
- •(inadequately
- •controlled).
- •\- Adolescent patients : If taking only ICS (without LABA) and are
Exclusion Criteria
- •\- Patients who have smoked or inhaled tobacco products (including
- •electronic cigarettes) within the 6 month period prior to Visit 1, or who
- •have a smoking history of greater than or equal to 10 pack year.
- •\- Patients who have had an asthma attack/exacerbation requiring
- •systemic steroids or hospitalization (\> 24 hours) or emergency room
- •visit (\= 24 hours) as follows:
- •For adults: within 6 weeks of Screening Visit. If patients experience an
- •asthma attack/exacerbation requiring systemic steroids or emergency
- •room visit between Visit 1 and Visit 102 they may be re\-screened 6
- •weeks after recovery
Outcomes
Primary Outcomes
Not specified
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