AsthmaPhase 2NCT00995904

Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

A Phase 2 study testing 84ug MAP0020, 42ug MAP0020 and 21ug MAP0020 in people with Asthma, run by Allergan at 2 sites 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

This Phase 2 study was to investigate the tolerability of unit dose budesonide (MAP0020) at three doses in pediatric volunteers with a diagnosis and history of mild-to-moderate stable asthma and evaluate the pharmacokinetic profile of budesonide resulting from inhalation aerosol delivery. Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Asthma
What is being tested?: 84ug MAP0020, 42ug MAP0020 and 21ug MAP0020
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 2 sitesUnited States
Study dates: Sep 2009to Nov 2009
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 4 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2
ICS users had to have been taking an ICS for >=3 months and on a stable dose for >= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Who cannot join

Females of child-bearing potential/menarche.
Diagnosis of any other significant chronic illness or abnormality.
Use of corticosteroids

Trial locations and contacts

2 sites in 1 country.

United States2 sites

West Coast Clinical Trials LLC
Cypress, California
Sylvana Research Associates
San Antonio, Texas

Other trials in United States

About this study

Official title: A Randomized, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma

Conditions: Asthma
Being tested: 84ug MAP0020, 42ug MAP0020, 21ug MAP0020
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.

84ug MAP0020Drug
84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
42ug MAP0020Drug
42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
21ug MAP0020Drug
21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol

Study groups in NCT00995904
Study group	Role	What they receive
Treatment A, then Treatment B, then Treatment C	Experimental	Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020
Treatment A, then Treatment C, then Treatment B	Experimental	Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020
Treatment B, then Treatment A, then Treatment C	Experimental	Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020
Treatment B, then Treatment C, then Treatment A	Experimental	Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020
Treatment C, then Treatment A, then Treatment B	Experimental	Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020
Treatment C, then Treatment B, then Treatment A	Experimental	Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4 Receives: Drug: 84ug MAP0020; Drug: 42ug MAP0020; Drug: 21ug MAP0020

What is being measured

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

Cmax of Budesonide After Administration of MAP0020
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
Measured: 12 hours
AUC(0-inf) of Budesonide After Administration of MAP0020
The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Measured: 12 hours
Half-life (t1/2) of Budesonide After Administration of MAP0020
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.
Measured: 12 hours

Timeline

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

Sep 2009Nov 2009

First posted15 Oct 2009 (estimated)
Study startSep 2009
Primary completionNov 2009
Study completionNov 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00995904
Sponsor's protocol ID: MAP0020-CL-P201
Status last verified: Dec 2013
First submitted: 6 Oct 2009
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, Open-Label, 3-Dose, 3-Period, Crossover Phase 2 Study Investigating the Tolerability and Pharmacokinetics of MAP0010 in Children 4 Through 11 Years Old With a History of Mild-To-Moderate Stable Asthma
ClinicalTrials.gov ID: NCT00995904
Acronym / sponsor ID: MAP0020-CL-P201
Conditions: Asthma
Keywords: asthmatic children
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Sep 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 15 Oct 2009 (estimated)
Results: Posted 20 Nov 2013

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Treatment A, then Treatment B, then Treatment C	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment A, then Treatment C, then Treatment B	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment B, then Treatment A, then Treatment C	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment B, then Treatment C, then Treatment A	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4
Treatment C, then Treatment A, then Treatment B	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment C, then Treatment B, then Treatment A	Experimental	Drug: 84ug MAP0020, Drug: 42ug MAP0020, Drug: 21ug MAP0020Study visits were separated by 3-7 day intervals. Treatment C: 21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 2; Treatment B: 42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 3; Treatment A: 84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) at Visit 4

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female children with a documented diagnosis of mild-to-moderate persistent asthma (according to the 2007 NIH [EPR] criteria) for at least 1 year prior to screening and medically stable for a minimum of 6 months prior to screening.
Children 4 through 11 years old (up to one day prior to their 12th birthday at randomization).
Body weight >=45 lbs, body mass index (BMI) <=30 kg/m2
ICS users had to have been taking an ICS for >=3 months and on a stable dose for >= 1 month before Visit 1.ICS users had to be stable enough and able to withhold their therapeutic ICS for 24 hours prior to study drug administration,
Subjects already on stable immunotherapy (ie, allergy shots)if not anticipated to change during the study.

Key exclusion criteria (3 listed)

Females of child-bearing potential/menarche.
Diagnosis of any other significant chronic illness or abnormality.
Use of corticosteroids

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
84ug MAP002084ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
42ug MAP002042ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A
21ug MAP002021ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol	Drug	Treatment A, then Treatment B, then Treatment C, Treatment A, then Treatment C, then Treatment B, Treatment B, then Treatment A, then Treatment C, Treatment B, then Treatment C, then Treatment A, Treatment C, then Treatment A, then Treatment B, Treatment C, then Treatment B, then Treatment A

Primary outcome

Cmax of Budesonide After Administration of MAP0020
Time frame: 12 hours
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).
AUC(0-inf) of Budesonide After Administration of MAP0020
Time frame: 12 hours
The AUC(0-inf) is the area under the plot of plasma concentration of drug to time infinity after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Half-life (t1/2) of Budesonide After Administration of MAP0020
Time frame: 12 hours
Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes.

Results and safety

Results posted to the registry on 20 Nov 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
Treatment A, Then Treatment B, Then Treatment C	4	4
Treatment A, Then Treatment C, Then Treatment B	3	3
Treatment B, Then Treatment A, Then Treatment C	4	4
Treatment B, Then Treatment C, Then Treatment A	5	5
Treatment C, Then Treatment A, Then Treatment B	5	5
Treatment C, Then Treatment B, Then Treatment A	4	4

Primary outcome: Cmax of Budesonide After Administration of MAP0020

Time frame: 12 hours. Mean (Standard Deviation). Unit: pg/ml

Measure	21ug MAP0020 n = 22	42ug MAP0020 n = 22	84ug MAP0020 n = 22
Value	92.5 (72.9)	175 (96.0)	370 (236)

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

Primary outcome: AUC(0-inf) of Budesonide After Administration of MAP0020

Time frame: 12 hours. Mean (Standard Deviation). Unit: pg*min/ml

Measure	21ug MAP0020 n = 22	42ug MAP0020 n = 22	84ug MAP0020 n = 22
Value	3750 (1560)	8710 (3270)	19400 (8230)

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

Primary outcome: Half-life (t1/2) of Budesonide After Administration of MAP0020

Time frame: 12 hours. Mean (Standard Deviation). Unit: minutes

Measure	21ug MAP0020 n = 22	42ug MAP0020 n = 22	84ug MAP0020 n = 22
Value	53.3 (31.2)	74.6 (29.8)	86.9 (29.0)

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

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
21ug MAP0020	0 of 25 (0%)	2 of 25 (8%)	Not reported
42ug MAP0020	0 of 24 (0%)	1 of 24 (4.2%)	Not reported
84ug MAP0020	0 of 24 (0%)	0 of 24 (0%)	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

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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.

Paul Ratner, MD principal investigator

Sylvana Research Associates

Ammar Hatab, MD principal investigator

West Coast Clinical Trials LLC

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 84ug MAP0020, 42ug MAP0020 and 21ug MAP0020 in people with Asthma, run by Allergan at 2 sites 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 3 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 2 sites 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. 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 20 Nov 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?

Cmax of Budesonide After Administration of MAP0020 (time frame: 12 hours). The study lists 3 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 NCT00995904.

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.