Trial Outcomes & Findings for Study of MAP0010 in Asthmatic Children and Adolescents (NCT NCT00697801)

Results Overview

The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

208 participants

Primary outcome timeframe

baseline, week 6

Results posted on

2014-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	MAP0010 High Dose a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo Placebo delivered by nebulization twice daily for 6 weeks
Overall Study STARTED	69	70	69
Overall Study COMPLETED	57	58	45
Overall Study NOT COMPLETED	12	12	24

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of MAP0010 in Asthmatic Children and Adolescents

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MAP0010 High Dose n=68 Participants a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose n=65 Participants a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo n=65 Participants Placebo delivered by nebulization twice daily for 6 weeks	Total n=198 Participants Total of all reporting groups
Age, Continuous	10.2 years STANDARD_DEVIATION 4.76 • n=5 Participants	10.5 years STANDARD_DEVIATION 4.75 • n=7 Participants	10.2 years STANDARD_DEVIATION 4.52 • n=5 Participants	10.3 years STANDARD_DEVIATION 4.68 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	20 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	40 Participants n=7 Participants	45 Participants n=5 Participants	126 Participants n=4 Participants

PRIMARY outcome

Timeframe: baseline, week 6

Population: Patients with available data at specified time points are included in the analysis population.

The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Daily composite symptom score is based on the average of the individual symptom scores for a day. Daytime composite symptom score is defined as average of the last 5 days' daily composite symptom scores within the last 5 days immediately preceding the end day of that week. The range for the daytime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Outcome measures

Outcome measures
Measure	MAP0010 High Dose n=68 Participants a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose n=65 Participants a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo n=65 Participants Placebo delivered by nebulization twice daily for 6 weeks
Change From Baseline in Daytime Composite Symptom Score Baseline	3.1 units on a scale Standard Deviation 1.90	2.8 units on a scale Standard Deviation 1.75	2.6 units on a scale Standard Deviation 1.59
Change From Baseline in Daytime Composite Symptom Score Change from Baseline at week 6	-0.7 units on a scale Standard Deviation 1.80	-1.4 units on a scale Standard Deviation 1.48	-0.6 units on a scale Standard Deviation 1.63

PRIMARY outcome

Timeframe: baseline, week 6

Population: Patients with available data at specified time points are included in the analysis population.

The individual symptoms at each time point to be monitored are: cough, wheeze, and shortness of breath. The individual symptoms were scored using a four point scale: 0=no symptoms; 1=mild symptoms; 2=moderate symptoms; 3=severe symptoms Nightly composite symptom score is based on the average of the individual symptom scores for the night. Nightime composite symptom score is defined as average of the last 5 days' nightly composite symptom scores within the last 5 nights immediately preceding the end day of that week. The range for the nighttime composite symptom score is 0 (no symptoms) to 3 (severe symptoms). A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.

Outcome measures

Outcome measures
Measure	MAP0010 High Dose n=68 Participants a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose n=65 Participants a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo n=65 Participants Placebo delivered by nebulization twice daily for 6 weeks
Change From Baseline in Nighttime Composite Symptom Score Change from Baseline at week 6	-0.6 units on a scale Standard Deviation 2.00	-1.2 units on a scale Standard Deviation 1.42	-0.4 units on a scale Standard Deviation 1.60
Change From Baseline in Nighttime Composite Symptom Score Baseline	2.7 units on a scale Standard Deviation 1.96	2.4 units on a scale Standard Deviation 1.75	2.4 units on a scale Standard Deviation 1.49

SECONDARY outcome

Timeframe: baseline, week 6

Population: Patients with available data at specified time points are included in the analysis population.

The forced expiratory volume in 1 second (FEV1) is the amount forced of air exhaled in 1 second. The percent predicted is calculated for age, gender, and height. Subjects had to perform at least 3 acceptable maneuvers into a spirometer. An increase indicates an improvement (a greater volume of air expired).

Outcome measures

Outcome measures
Measure	MAP0010 High Dose n=17 Participants a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose n=16 Participants a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo n=14 Participants Placebo delivered by nebulization twice daily for 6 weeks
Change From Baseline in FEV1% Predicted Change from Baseline at 6 weeks	6.3 percentage of predicted FEV1 Standard Deviation 9.87	6.3 percentage of predicted FEV1 Standard Deviation 7.73	5.9 percentage of predicted FEV1 Standard Deviation 8.73
Change From Baseline in FEV1% Predicted Baseline	74.8 percentage of predicted FEV1 Standard Deviation 11.45	73.8 percentage of predicted FEV1 Standard Deviation 13.10	65.9 percentage of predicted FEV1 Standard Deviation 7.22

Adverse Events

MAP0010 High Dose

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

MAP0010 Low Dose

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MAP0010 High Dose n=69 participants at risk a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	MAP0010 Low Dose n=67 participants at risk a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Placebo n=69 participants at risk Placebo delivered by nebulization twice daily for 6 weeks
Infections and infestations Nasopharyngitis	8.7% 6/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	3.0% 2/67 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	4.3% 3/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
Infections and infestations Upper Respiratory Infection	11.6% 8/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	9.0% 6/67 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	17.4% 12/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.
Respiratory, thoracic and mediastinal disorders Asthma	10.1% 7/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	3.0% 2/67 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.	7.2% 5/69 All patients who received any study drug and who had at least one post safety evaluation were included in the adverse event analysis.

Additional Information

VP, Scientific Affairs

MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

Phone: 650-386-3100

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER