Trial Outcomes & Findings for A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma (NCT NCT00590720)
NCT ID: NCT00590720
Last Updated: 2014-03-21
Results Overview
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
TERMINATED
PHASE2
11 participants
Days 0 - 150
2014-03-21
Participant Flow
A total of 11 subjects participated in this study from 26Feb2008 to 27Dec2008 at 4 sites in the United States of America.
Treatment assignments were determined using a block randomization procedure with a 2:1 ratio (MEDI-528:placebo) via an interactive voice response system on Day 0 before study drug administration.
Participant milestones
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma
Baseline characteristics by cohort
| Measure |
PLACEBO
n=4 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.8 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
32.0 Years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: All participants who received at least one dose of investigational product (MEDI-528 or placebo).
Number of participants experiencing adverse events (includes both adverse events and serious adverse events)
Outcome measures
| Measure |
PLACEBO
n=4 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Incidence of Adverse Events
|
4 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Days 0 - 150Population: All participants who received at least one dose of investigational product (MEDI-528 or placebo).
Number of participants experiencing serious adverse events
Outcome measures
| Measure |
PLACEBO
n=4 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Incidence of Serious Adverse Events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 0, 28, 56, 119, and 150Population: All participants who received at least one dose of MEDI-528.
Number of participants with ADA to MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, with 2 placebo and 7 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 measured before and after exercising on Day 28.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-0.43 Liter
Standard Deviation 0.23
|
-0.21 Liter
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 56.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-0.60 Liter
Standard Deviation 0.04
|
-0.02 Liter
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the maximum change in FEV1 before and after exercise on Day 150.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Absolute Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-0.54 Liter
Standard Deviation 0.62
|
-0.13 Liter
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and performed acceptable spirometry (n=9, 2 placebo and 7 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 28.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-12.6 Percent change
Standard Deviation 1.53
|
-6.49 Percent change
Standard Deviation 11.73
|
SECONDARY outcome
Timeframe: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 56.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-20.1 Percent change
Standard Deviation 7.41
|
-1.01 Percent change
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
The clinical activity of MEDI-528 on exercise-induced bronchoconstriction was measured by exercise challenge testing expressed as the percent maximum change in FEV1 before and after exercise on Day 150.
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Percent Maximum Change in Forced Expiratory Volume in 1 Second (FEV1)
|
-15.2 Percent change
Standard Deviation 15.48
|
-5.04 Percent change
Standard Deviation 3.91
|
SECONDARY outcome
Timeframe: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
AUC of FEV1 at Day 28
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
|
92.69 Liter x min
Standard Deviation 41.14
|
86.04 Liter x min
Standard Deviation 15.62
|
SECONDARY outcome
Timeframe: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).
AUC of FEV1 at Day 56
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=5 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
|
85.38 Liter x min
Standard Deviation 44.72
|
83.35 Liter x min
Standard Deviation 22.66
|
SECONDARY outcome
Timeframe: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=7, 2 placebo and 5 MEDI-528).
AUC of FEV1 at Day 150
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=5 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1)
|
82.53 Liter x min
Standard Deviation 18.31
|
81.37 Liter x min
Standard Deviation 19.93
|
SECONDARY outcome
Timeframe: Day 28 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=9, 2 placebo and 7 MEDI-528).
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after 30 minues of exercise on Day 28
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
|
10.00 Minutes
Standard Deviation 0.00
|
5.71 Minutes
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Day 56 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 56
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
|
10.00 Minutes
Standard Deviation 0.00
|
5.00 Minutes
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Day 150 (15 minutes prior to exercise and 5, 10, 15, 20, and 30 minutes after exercise)Population: All participants who received at least 4 doses of investigational product (MEDI-528 or placebo; n=10, 3 placebo and 7 MEDI-528) and had available data (n=8, 2 placebo and 6 MEDI-528).
Time to return in minutes to 90 percent of baseline FEV1 (prior to exercise) after exercise on Day 150
Outcome measures
| Measure |
PLACEBO
n=2 Participants
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=6 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Time to Return in Minutes to 90 Percent of Baseline Forced Expiratory Volume in 1 Second (FEV1)
|
7.50 Minutes
Standard Deviation 3.54
|
5.00 Minutes
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150Population: All participants who received at least one dose of MEDI-528.
Cmin of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Mean Trough Concentration (Cmin)
|
—
|
2.207 Microgram per milliliter
Standard Deviation 1.694
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150Population: All participants who received at least one dose of MEDI-528.
Cmin\_last of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Mean Trough Concentration at Last Measurable Time Point (Cmin_last)
|
—
|
18.123 Microgram per milliliter
Standard Deviation 10.456
|
SECONDARY outcome
Timeframe: Days 0, 3, 7, 10, 14, 17, 21, 24, 28, 32, 37, 42, 56, 70, 84, 119, and 150Population: All participants who received at least one dose of MEDI-528.
T1/2 of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=7 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Half-life (T1/2)
|
—
|
34.708 Day
Standard Deviation 7.891
|
SECONDARY outcome
Timeframe: Days 0 and 24Population: All participants who received at least one dose of MEDI-528 (n=7) and had available data (n=5).
Ratio of trough concentrations after first (Day 0) and last (Day 24) dose of MEDI-528
Outcome measures
| Measure |
PLACEBO
Placebo administered as a subcutaneous injection twice weekly for 4 weeks
|
MEDI528 50 mg
n=5 Participants
MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
|
|---|---|---|
|
Accumulation Index
|
—
|
7.615 Ratio
Standard Deviation 5.215
|
Adverse Events
PLACEBO
MEDI528 50 mg
Serious adverse events
| Measure |
PLACEBO
n=4 participants at risk
|
MEDI528 50 mg
n=7 participants at risk
|
|---|---|---|
|
Investigations
Nuclear magnetic resonance imaging abnormal
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
Other adverse events
| Measure |
PLACEBO
n=4 participants at risk
|
MEDI528 50 mg
n=7 participants at risk
|
|---|---|---|
|
General disorders
Cyst
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Injection site irritation
|
25.0%
1/4 • Number of events 2
|
14.3%
1/7 • Number of events 2
|
|
Immune system disorders
Drug hypersensitivity
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Acute sinusitis
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Eye infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Infections and infestations
Viral upper respiratory tract infection
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Injury
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Investigations
Blood bicarbonate increased
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Investigations
Blood glucose increased
|
0.00%
0/4
|
28.6%
2/7 • Number of events 3
|
|
Investigations
Lipase increased
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Hyposmia
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Nervous system disorders
Nerve root compression
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER