AsthmaPhase 2NCT00697801

Study of MAP0010 in Asthmatic Children and Adolescents

A Phase 2 study testing MAP0010 low dose and MAP0010 high dose in people with Asthma, run by Allergan at 1 site in United States.

Completed

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

Official record

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Trial summary

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents. Read more about this study

Who is it for?: Ages 1 year to 18 years
Conditions the study is for: Asthma
What is being tested?: MAP0010 low dose and MAP0010 high dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 208 participants
Where: 1 siteUnited States
Study dates: Jul 2006to Dec 2006
Phase: Phase 2
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 1 year to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Male or female asthmatic children/adolescents
1 to 18 years of age
FEV1 greater than or equal to 50% predicted normal (where obtainable)
Stable but symptomatic
Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.

Who cannot join

Any other significant childhood illness.
Participated in any investigational clinical trial within the 30 days prior to screening.
Use of any corticosteroid within 2 weeks of screening.
Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
Use of inhaled long acting bronchodilators.
Presumptive or documented history of upper or lower respiratory infection within 2 weeks before screening.
Any history of acute or severe asthma attack requiring ICU admission or ventilatory support.
History suggestive (or diagnosis) of other concomitant lung disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
San Diego, California

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Placebo Controlled, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks

The objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

Conditions: Asthma
Being tested: MAP0010 low dose, MAP0010 high dose, Placebo
Medical subject headings: Asthma

What participants receive

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

MAP0010 low doseDrug
a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high doseDrug
a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
PlaceboDrug
Placebo delivered by nebulization twice daily for 6 weeks

Study groups in NCT00697801
Study group	Role	What they receive
MAP0010 low dose	Experimental	a single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks Receives: Drug: MAP0010 low dose
MAP0010 high dose	Experimental	a single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks Receives: Drug: MAP0010 high dose
Placebo	Placebo comparator	Placebo delivered by nebulization twice daily for 6 weeks Receives: Drug: Placebo

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 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.
Measured: baseline, week 6
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 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.
Measured: baseline, week 6

Secondary outcomes (1)

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. An increase indicates an improvement (a greater volume of air expired).
Measured: baseline, week 6

Timeline

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

Jul 2006Dec 2006

First posted16 Jun 2008 (estimated)
Study startJul 2006
Primary completionDec 2006
Study completionDec 2006

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00697801
Sponsor's protocol ID: MAP0010-CL-P201
Status last verified: Dec 2013
First submitted: 12 Jun 2008
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?

See locations

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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, 3 Arm, Parallel Group, Phase 2 Study Investigating the Efficacy, Tolerability and Pharmacokinetics of MAP0010 in Asthmatic Children and Adolescents Over 6 Weeks
ClinicalTrials.gov ID: NCT00697801
Acronym / sponsor ID: MAP0010-CL-P201
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Jul 2006
Primary completion: Dec 2006 (actual)
Study completion: Dec 2006 (actual)
First posted: 16 Jun 2008 (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 objectives of this study are to evaluate the efficacy, tolerability and pharmacokinetics of 2 doses of MAP0010 (Unit Dose Budesonide) in asthmatic children/adolescents.

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
MAP0010 low dose	Experimental	Drug: MAP0010 low dosea single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks
MAP0010 high dose	Experimental	Drug: MAP0010 high dosea single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks
Placebo	Placebo comparator	Drug: PlaceboPlacebo delivered by nebulization twice daily for 6 weeks

Who may qualify

Ages: 1 year to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

Male or female asthmatic children/adolescents
1 to 18 years of age
FEV1 greater than or equal to 50% predicted normal (where obtainable)
Stable but symptomatic
Diagnosis of asthma (per NIH criteria) at least 3 months before screening OR documented exacerbation or worsening of asthma or symptoms suggestive of asthma including nocturnal asthma, within 6 months of screening OR documented SAB use more than or at least once for symptom relief during the 4 days of run in with a total symptom score greater than or equal to 1 OR greater than or equal to 1 night disturbed due to asthma symptoms in previous month.

Key exclusion criteria (8 listed)

Any other significant childhood illness.
Participated in any investigational clinical trial within the 30 days prior to screening.
Use of any corticosteroid within 2 weeks of screening.
Use of oral corticosteroid within 30 days of screening or prolonged use of oral corticosteroids within 12 weeks of screening.
Use of inhaled long acting bronchodilators.

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
MAP0010 low dosea single dose of MAP0010 low dose delivered by nebulization twice daily for 6 weeks	Drug	MAP0010 low dose
MAP0010 high dosea single dose of MAP0010 high dose delivered by nebulization twice daily for 6 weeks	Drug	MAP0010 high dose
PlaceboPlacebo delivered by nebulization twice daily for 6 weeks	Drug	Placebo

Primary outcome

Change From Baseline in Daytime Composite Symptom Score
Time frame: baseline, week 6
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.
Change From Baseline in Nighttime Composite Symptom Score
Time frame: baseline, week 6
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.

1 secondary outcome

Change From Baseline in FEV1% Predicted
Time frame: baseline, week 6

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
MAP0010 High Dose	69	57
MAP0010 Low Dose	70	58
Placebo	69	45

Primary outcome: Change From Baseline in Daytime Composite Symptom Score

Time frame: baseline, week 6. Mean (Standard Deviation). Unit: units on a scale

Measure	MAP0010 High Dose n = 68	MAP0010 Low Dose n = 65	Placebo n = 65
Baseline	3.1 (1.90)	2.8 (1.75)	2.6 (1.59)
Change from Baseline at week 6	-0.7 (1.80)	-1.4 (1.48)	-0.6 (1.63)

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

Primary outcome: Change From Baseline in Nighttime Composite Symptom Score

Time frame: baseline, week 6. Mean (Standard Deviation). Unit: units on a scale

Measure	MAP0010 High Dose n = 68	MAP0010 Low Dose n = 65	Placebo n = 65
Baseline	2.7 (1.96)	2.4 (1.75)	2.4 (1.49)
Change from Baseline at week 6	-0.6 (2.00)	-1.2 (1.42)	-0.4 (1.60)

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

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MAP0010 High Dose	0 of 69 (0%)	21 of 69 (30.4%)	Not reported
MAP0010 Low Dose	0 of 67 (0%)	10 of 67 (14.9%)	Not reported
Placebo	0 of 69 (0%)	20 of 69 (29%)	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.

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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, Inc., a wholly owned subsidiary of Allergan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MAP0010 low dose and MAP0010 high dose in people with Asthma, run by Allergan at 1 site in United States.

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 8 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.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6). 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 NCT00697801.

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.