Trial Outcomes & Findings for Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells (NCT NCT01082952)

NCT ID: NCT01082952

Last Updated: 2011-11-18

Results Overview

Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.

• Recruitment status: COMPLETED
• Target enrollment: 12 participants
• Primary outcome timeframe: one day
• Results posted on: 2011-11-18

Participant Flow

recruitment started January 2010 and ended July 2011. Recruitment was all in King Khalid Hospital, Riyadh, Saudi Arabia

Participant milestones

Measure	Asthmatic Patients Patients were severe asthmatic with high peripheral blood eosinophil counts (\>5%).	Non Asthmatic Patients Non asthmatic patients with high eosinophil count (\>3%).
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Eosinophils in the Proliferation of Airway Smooth Muscle (ASM) Cells

Baseline characteristics by cohort

Measure	Asthmatic Patients n=6 Participants Patients were severe asthmatic with high peripheral blood eosinophil counts (\>5%).	Non Asthmatic Patients n=6 Participants Non asthmatic patients with high eosinophil count (\>3%).	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	23 years STANDARD_DEVIATION 3 • n=5 Participants	24 years STANDARD_DEVIATION 2.5 • n=7 Participants	23.5 years STANDARD_DEVIATION 2.75 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment Saudi Arabia	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: one day

Population: The number of participants for each group was determined to insure proper statistical significance when analysing the effect of isolated eosinophils on ASM cells proliferation

Airway Smooth Muscle (ASM) cell proliferation was measured 24 hrs following their co-culture with eosinophil. This was determined using Ki-67 staining and flowcytometry. The fold increase in ASM proliferation was then determined.

Outcome measures

Measure	Asthmatic Patients n=6 Participants Mild asthmatic patients with high eosinophil count (\>5%)	Non Asthmatic Patients n=6 Participants Non asthmatic patients with high Eosinophil count (\>3%)
Fold Increase in ASM Proliferation Following Incubation With Eosinophils.	2 Fold increase in ASM cell proliferation Standard Deviation 0.2	2 Fold increase in ASM cell proliferation Standard Deviation 0.3

SECONDARY outcome

Timeframe: one day

Population: Eosinophils were collected from all the participants and used to trigger ASM proliferation.

The effect of Eosinophil release of Cysteinyl Leukotrienes on ASM proliferation was determined using blocking agents. This was determined using Ki-67 staining and flowcytometry.

Outcome measures

Measure	Asthmatic Patients n=6 Participants Mild asthmatic patients with high eosinophil count (\>5%)	Non Asthmatic Patients n=6 Participants Non asthmatic patients with high Eosinophil count (\>3%)
Fold Increase in ASM Cells Proliferation Following Treatment With Cysteinyl Leukotrienes	2.3 Fold increase in ASM proliferation Standard Deviation 0.2	2.5 Fold increase in ASM proliferation Standard Deviation 0.1

Adverse Events

Asthmatic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non Asthmatic Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rabih Halwani

King Saud University

Phone: 00966551307134

Email: rhalwani@ksu.edu.sa

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place