AsthmaPhase 3NCT00569192

A Study of 2 Doses of MAP0010 and Placebo in Asthmatic Children

A Phase 3 study testing 0.135mg MAP0010 and 0.25mg MAP0010 in people with Asthma, run by Allergan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period. Read more about this study

Who is it for?: Ages 12 months to 8 years
Conditions the study is for: Asthma
What is being tested?: 0.135mg MAP0010 and 0.25mg MAP0010
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: No sites listed yet
Study dates: Dec 2007to Jan 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 months to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female asthmatic children with mild to moderate persistent asthma.
12 months to 8 years of age.
For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
AND with at least one major or two minor risk factors.

Who cannot join

Any other significant childhood illness/abnormality or chronic lung disease
Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Conditions: Asthma
Being tested: 0.135mg MAP0010, 0.25mg MAP0010, Placebo
Keywords: asthmatic children
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

0.135mg MAP0010Drug
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
0.25mg MAP0010Drug
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
PlaceboDrug
Placebo delivered by nebulization twice daily for 12 weeks

Study groups in NCT00569192
Study group	Role	What they receive
0.25mg MAP0010	Experimental	0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks Receives: Drug: 0.25mg MAP0010
Placebo	Placebo comparator	Placebo delivered by nebulization twice daily for 12 weeks Receives: Drug: Placebo
0.135mg MAP0010	Experimental	0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks Receives: Drug: 0.135mg MAP0010

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Daytime Composite Symptom Score
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 7 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.
Measured: baseline, week 12
Change From Baseline in Nighttime Composite Symptom Score
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 7 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.
Measured: baseline, week 12

Secondary outcomes (4)

Change From Baseline in FEV1% Predicted
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 and the largest volume from the 3 maneuvers was selected. An increase indicates an improvement (a greater volume of air expired).
Measured: baseline, week 12
Change From Baseline in PEF
The peak expiratory flow (PEF) is the highest air flow achieved from a maximum forced expiratory maneuver measured in liters of air per minute (L/min). Subjects had to perform at least 3 acceptable maneuvers into a PEF meter. An increase indicates an improvement (a greater volume of air expired).
Measured: baseline, week 12
Change From Baseline in Daytime Individual Symptom Scores
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
Individual Daytime symptom score is defined as an average of the last 5 days' individual symptom scores within the last 7 days immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
Measured: baseline, week 12
Change From Baseline in Nighttime Individual Symptom Scores
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
Individual nighttime symptom score is defined as an average of the last 5 nights' individual symptom scores within the last 7 nights immediately preceding the end day of that week. A negative change indicates an improvement of symptoms and a positive change indicates a worsening of symptoms.
Measured: baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Jan 2009

First posted7 Dec 2007 (estimated)
Study startDec 2007
Primary completionSep 2008
Study completionJan 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00569192
Sponsor's protocol ID: MAP0010-CL-P301
Status last verified: Dec 2013
First submitted: 5 Dec 2007
Last updated: 9 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Study Investigating the Safety and Efficacy Over 12 Weeks Treatment Period of MAP0010 in Asthmatic Infants and Children 12 Months to 8 Years of Age
ClinicalTrials.gov ID: NCT00569192
Acronym / sponsor ID: MAP0010-CL-P301
Conditions: Asthma
Keywords: asthmatic children
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Dec 2007
Primary completion: Sep 2008 (actual)
Study completion: Jan 2009 (actual)
First posted: 7 Dec 2007 (estimated)
Results: Posted 23 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
0.25mg MAP0010	Experimental	Drug: 0.25mg MAP00100.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo delivered by nebulization twice daily for 12 weeks
0.135mg MAP0010	Experimental	Drug: 0.135mg MAP00100.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks

Who may qualify

Ages: 12 months to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female asthmatic children with mild to moderate persistent asthma.
12 months to 8 years of age.
For children age 4 to 8 years: Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH (EPR-3) criteria.
For infants age 12 to <48 months old: 2 or more wheezing episodes in past 12 months which lasted > 1 day and affected sleep.
AND with at least one major or two minor risk factors.

Key exclusion criteria (5 listed)

Any other significant childhood illness/abnormality or chronic lung disease
Any history of upper or lower respiratory tract infection, within 2 weeks of screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
Use of any corticosteroid, including inhaled, parental, intranasal, or topical corticosteroid within 2 weeks of screening.
Any use of oral corticosteroids within 30 days of screening or prolonged use (>10 consecutive days) of oral corticosteroids, within 12 weeks of screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
0.135mg MAP00100.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks	Drug	0.135mg MAP0010
0.25mg MAP00100.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks	Drug	0.25mg MAP0010
PlaceboPlacebo delivered by nebulization twice daily for 12 weeks	Drug	Placebo

Primary outcome

Change From Baseline in Daytime Composite Symptom Score
Time frame: baseline, week 12
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 7 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.
Change From Baseline in Nighttime Composite Symptom Score
Time frame: baseline, week 12
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 7 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.

4 secondary outcomes

Change From Baseline in FEV1% Predicted
Time frame: baseline, week 12
Change From Baseline in PEF
Time frame: baseline, week 12
Change From Baseline in Daytime Individual Symptom Scores
Time frame: baseline, week 12
Change From Baseline in Nighttime Individual Symptom Scores
Time frame: baseline, week 12

Results and safety

Results posted to the registry on 23 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	111	88
0.135 mg MAP0010	125	105
0.25 mg MAP0010	124	99

Primary outcome: Change From Baseline in Daytime Composite Symptom Score

Time frame: baseline, week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 110	0.135 mg MAP0010 n = 122	0.25 mg MAP0010 n = 117
Baseline	2.73 (1.406)	2.96 (1.329)	2.87 (1.383)
Change from Baseline at week 12	-1.38 (1.722)	-1.77 (1.618)	-1.56 (1.591)

Population analysed: Intent-to-treat includes all randomized patients who have received at least one dose of study drug and have baseline and at least one post treatment efficacy assessment available.

Primary outcome: Change From Baseline in Nighttime Composite Symptom Score

Time frame: baseline, week 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 110	0.135 mg MAP0010 n = 122	0.25 mg MAP0010 n = 117
Baseline	2.71 (1.393)	2.97 (1.466)	2.82 (1.349)
Change from Baseline at week 12	-1.47 (1.572)	-1.82 (1.907)	-1.59 (1.516)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 110 (0.9%)	33 of 110 (30%)	Not reported
0.135 mg MAP0010	2 of 123 (1.6%)	31 of 123 (25.2%)	Not reported
0.25 mg MAP0010	0 of 123 (0%)	42 of 123 (34.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Asthma

RecruitingPhase 1
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RecruitingPhase 1
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RecruitingPhase 3
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

MAP Pharmaceuticals

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 0.135mg MAP0010 and 0.25mg MAP0010 in people with Asthma, run by Allergan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Daytime Composite Symptom Score (time frame: baseline, week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00569192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2014.