Phase 3
N=10
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02097537 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL — 7 percentage of the subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Methacholine Chloride (SK-1211) (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL |
7 | — |
| SECONDARY The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation |
7 | — |
| SECONDARY The Summary Statistics of PC20 |
8.0674 | — |
Summary
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of bronchial asthma
- FEV1/FVC must be 70% or more
- 200, or diastolic BP>100
- known aortic aneurysm
Data sourced from ClinicalTrials.gov (NCT02097537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.