Trial Outcomes & Findings for Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma (NCT NCT00683449)
NCT ID: NCT00683449
Last Updated: 2011-10-07
Results Overview
The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline and Hour 2
Results posted on
2011-10-07
Participant Flow
Upon presentation to the Emergency Department (ED) at a hospital participating in the study with an acute exacerbation of asthma, the Principal Investigator (ED physician) discussed the study with the potential subject.
Some subjects were consented for the study, but upon screening, failed to meet the inclusion and exclusion criteria, had an FEV1 \> 50%, or refused to participate.
Participant milestones
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
13
|
3
|
6
|
2
|
|
Overall Study
COMPLETED
|
5
|
12
|
3
|
6
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study Evaluating the Safety and Effects of MN-221 in Subjects Experiencing an Acute Exacerbation of Asthma
Baseline characteristics by cohort
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 Participants
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 Participants
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=3 Participants
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=6 Participants
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 Participants
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age Continuous
|
30.2 years
STANDARD_DEVIATION 11.56 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
22.3 years
STANDARD_DEVIATION 3.21 • n=5 Participants
|
39.2 years
STANDARD_DEVIATION 9.77 • n=4 Participants
|
45 years
STANDARD_DEVIATION 0.0 • n=21 Participants
|
37.83 years
STANDARD_DEVIATION 11.31 • n=8 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
21 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
13 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
2 participants
n=21 Participants
|
29 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Hour 2Population: The analysis was performed on the Intention-to-Treat (ITT) population. Twenty-nine subjects met the study entry criteria, provided written informed consent, and were enrolled in the study.
The primary efficacy summary was change from Baseline in FEV1 (percent predicted), at Hour 2. Baseline was defined as FEV1 (percent predicted) after two doses of albuterol (5 mg each) and ipratropium (0.5 mg each) and FEV1 (percent predicted) FEV1 at Hour 2 was defined as the FEV1 (percent predicted) at 2 hours after the start of the infusion of MN-221 or placebo. Change from Baseline in FEV1 (percent predicted), was summarized by treatment group at Hour 2.
Outcome measures
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 Participants
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 Participants
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=3 Participants
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=6 Participants
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 Participants
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Change of FEV1 (Forced Expiratory Volume in 1 Second) Expressed as Percent of Predicted After Two Doses of Albuterol (5 mg Each) and Ipratropium (0.5 mg Each) When Compared to FEV1 at Hour 2 After the Start of the Infusion of MN-221 or Placebo.
|
16.57 FEV1 (percent of predicted)
Full Range 11.17 • Interval 4.8 to 44.7
|
3.88 FEV1 (percent of predicted)
Full Range 7.79 • Interval -13.2 to 19.9
|
3.03 FEV1 (percent of predicted)
Interval -0.4 to 6.0
|
4.27 FEV1 (percent of predicted)
Interval -3.3 to 11.9
|
-0.82 FEV1 (percent of predicted)
Interval -2.4 to 0.8
|
SECONDARY outcome
Timeframe: Baseline to Hour 2Population: 29 subjects experiencing an acute exacerbation of asthma were at approximately 8 ED sites. The sample size was based on feasibility and precedent for this type of study, rather than statistical considerations.
FEV1 (L) was determined over time using a spirometer. Measure the mean change in FEV1 (L) from Baseline.
Outcome measures
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 Participants
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 Participants
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=6 Participants
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=3 Participants
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 Participants
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
FEV1 (L) The Forced Expiratory Volume in One Second as Measured in Liters Per Second.
|
0.60 liters per second
Interval 0.14 to 1.67
|
0.10 liters per second
Interval -0.51 to 0.54
|
0.12 liters per second
Interval -0.09 to 0.33
|
0.10 liters per second
Interval -0.02 to 0.22
|
-0.02 liters per second
Interval -0.07 to 0.02
|
SECONDARY outcome
Timeframe: Hour -1.5 through Hour 5After a patient in the emergency department (ED) presents with an acute exacerbation of asthma, the hospital proceeds with SOC procedures for this condition. Despite treatment in the ED, it is sometimes necessary to admit the patient into the hospital. In the study described here, the rate of hospital admissions was recorded.
Outcome measures
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 Participants
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 Participants
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=3 Participants
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=6 Participants
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 Participants
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Hospital Admission Rate During Visit 1
|
0 participants
|
7 participants
|
0 participants
|
3 participants
|
1 participants
|
Adverse Events
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
MN-221 Placebo i.v. Infusion
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
1,000-1,080 μg MN-221 i.v.
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
450 μg MN-221 i.v. for 15 Minutes
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 participants at risk
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 participants at risk
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=3 participants at risk
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=6 participants at risk
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 participants at risk
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
|
0.00%
0/5
|
30.8%
4/13 • Number of events 4
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
50.0%
1/2 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
Other adverse events
| Measure |
240 μg MN-221 i.v. (Intravenous) Infusion for 15 Minutes
n=5 participants at risk
Initial dose: 16 μg/min of MN-221 for 15 minutes (total 240 μg). After safety data review meeting, chose escalation doses: 1) 30 μg/min for 15 minutes (total 450 μg), and 2) 16 μg/min for 15 minutes plus 8 μg/min for 105 minutes (total dose of 1,080 μg).Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period:
* Assessment of subject's signs and symptoms
* Completion of a dyspnea index scale
* Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%
* Albuterol (2.5 mg) via nebulizer given hourly NOTE: Albuterol (2.5 mg) via nebulizer and/or Ipratropium (0.5 mg) via nebulizer may have been given up to every 20 minutes and every hour, respectively, if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subj
|
MN-221 Placebo i.v. Infusion
n=13 participants at risk
MN-221 Placebo i.v. infusion. Until the subject's FEV1 reached ≥ 70% predicted, the subject continued to receive the following standard treatment and assessment during the study treatment period: Assessment of subject's signs and symptoms,Completion of a dyspnea index scale,Supplemental oxygen to maintain oxygen saturation, as measured by pulse oximetry of ≥ 90%,Albuterol (2.5 mg) via nebulizer given hourly. NOTE: Albuterol (2.5 mg) via nebulizer may have been given up to every 20 minutes if deemed to be indicated by the Investigator.
* Ipratropium (0.5 mg) via nebulizer may have been given every hour if deemed to be indicated by the Investigator.
* Spirometry completed within 10 minutes of nebulizer treatments, followed by
* Reassessment of signs and symptoms. If the subject did not improve to FEV1 ≥70% of predicted during the study treatment period, the subject may have continued to receive further treatment, including hospital admission, at the discretion of the Investigator.
|
1,000-1,080 μg MN-221 i.v.
n=3 participants at risk
16 μg/minute for 15 minutes followed by 8 μg/minute for 105 minutes (total dose of 1,080 μg). Among the subjects in the 1,000 - 1,080 μg group, per protocol instructions, the two subjects originally randomized to receive 1,080 μg MN-221 were infused with study drug over a 120-minute period and the 1 subject originally randomized to receive 450 μg who actually received 1,000 μg was infused with study drug over a 15-minute period. Although there was this difference in infusion time, it was deemed appropriate to group these 3 subjects in the same dose group.
|
450 μg MN-221 i.v. for 15 Minutes
n=6 participants at risk
30 μg/minute for 15 minutes (total dose of 450 μg) administered i.v.
|
1,995 μg MN-221 i.v. Over 15 Minutes and 25 Minutes
n=2 participants at risk
Two subjects were randomized to receive 450 μg dose i.v. Instead, Subject 0010015 received 1,995 μg i.v. over 15 minutes infusion; Subject 0010016 received 1,995 μg i.v. over 25 minutes infusion.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
60.0%
3/5 • Number of events 19
|
46.2%
6/13 • Number of events 12
|
0.00%
0/3
|
16.7%
1/6 • Number of events 3
|
100.0%
2/2 • Number of events 2
|
|
Investigations
Lymphocyte count decreased
|
40.0%
2/5 • Number of events 4
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
Blood lactic acid increased
|
40.0%
2/5 • Number of events 2
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
Blood potassium decreased
|
60.0%
3/5 • Number of events 3
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Blood and lymphatic system disorders
Monocyte count decreased
|
40.0%
2/5 • Number of events 2
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Investigations
Blood bicarbonate decreased
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.00%
0/5
|
0.00%
0/13
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/5
|
0.00%
0/13
|
0.00%
0/3
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/5
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
50.0%
1/2 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
1/5 • Number of events 1
|
0.00%
0/13
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
|
Nervous system disorders
Headache
|
0.00%
0/5
|
7.7%
1/13 • Number of events 1
|
0.00%
0/3
|
0.00%
0/6
|
0.00%
0/2
|
Additional Information
Kazuko Matsuda, MD PhD MPH, Vice President, Clinical Development
MediciNova, Inc.
Phone: 858-373-1500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60