N/A
N=12
Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT01082952 ↗Enrolled (actual)
12
Serious AEs
—
Results posted
Nov 2011
Primary outcome: Primary: Fold Increase in ASM Proliferation Following Incubation With Eosinophils. — 2; 2 Fold increase in ASM cell proliferation — p=<0.05
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult · 14+ yrs
- Sex
- All
- Sponsor
- King Saud University
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fold Increase in ASM Proliferation Following Incubation With Eosinophils. |
2; 2 | <0.05 sig |
| SECONDARY Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes |
2.3; 2.5 | — |
Summary
Being a key player in Asthma, eosinophils constitute a potential target to interfere with the series of biological events leading to Asthma pathogenesis. In this proposal, the investigators hypothesize that the interaction between eosinophils and airway smooth muscle cells (ASM) cells plays an important role in airway remodeling. Hence the investigators will investigate the role of eosinophils in enhancing ASM cells proliferation resulting in airways remodeling. The investigators will also investigate the mechanism behind this phenomenon. This will then pave the way for medical (drug) interference at one or several sites in order to prevent one of the main potential reasons behind airway remodeling, namely eosinophil-derived ASM proliferation.
Eligibility Criteria
Asthma: Patient Selection (Inclusion Criteria)
- Subjects with documented clinical history of asthma for a period of at least 6 months prior to study entry (and a minimum of one clinic follow-up visit since initial diagnosis)
- Willing to provide written informed consent and in the judgment of the investigator, individuals who are able to understand the informed consent process.
- Subjects with documented clinical history (in preceding 12 months) of airway reversibility of at least 12% based on Forced Expiratory Volume (FEV1), measured pre and post inhalation of a β-2 agonist (2 puffs of albuterol using a measured dose inhaler with spacer) OR
- Individuals with strong history of asthma but with waning, or no current symptoms may be included in the study if their asthma was well controlled using an asthma medication. Principal investigator must verify or know the clinical history of an individual before accepting him as an asthmatic individual.
- Able to perform Spirometry/FEV1 correctly.
Exclusion Criteria
- Age < 5 years
- Smoking for 20 years, 1 pack/day or more.
- Congestive heart failure.
- Chronic Obstructive Pulmonary Disease (COPD).
- Chronic lung disease other than asthma and COPD.
- Bronchiectasis.
Data sourced from ClinicalTrials.gov (NCT01082952). 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.