AsthmaPhase 2P202NCT00554970

A Study of 2 Doses of MAP0010 in Adult Asthmatics

A Phase 2 study testing MAP0010 low dose, MAP0010 high dose and Budesonide inhalation suspension 0.25mg 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 purpose of this study is to examine the blood levels of two doses of MAP0010 (a corticosteroid) and two doses of an approved corticosteroid in adult asthma and safety with twice daily dosing over 7 days. Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Asthma
What is being tested?: MAP0010 low dose, MAP0010 high dose and Budesonide inhalation suspension 0.25mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: Nov 2007to Mar 2008
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 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female adult asthmatics with mild to moderate persistent asthma.
18 to 45 (up to the 46th birthday) years of age.
Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
Baseline FEV1 greater than or equal to 50% of predicted normal.

Who cannot join

Any other significant illness/abnormality
A history of upper or lower respiratory tract infection within 2 weeks
A history of acute or severe asthma attack requiring ICU admission or ventilatory support.

Trial locations and contacts

1 site in 1 country.

United States1 site

West Coast Clinical Trials Phase 2-4, LLC
Long Beach, California, 90806

Other trials in United States

About this study

Official title: A Randomized, Open Label, Active-Controlled, 4-Treatment, 2-Period, 2 Parallel Block Crossover Pharmacokinetic and Safety Study of 2 Doses of MAP0010 in Adult Asthmatics

Conditions: Asthma
Being tested: MAP0010 low dose, MAP0010 high dose, Budesonide inhalation suspension 0.25mg, Budesonide inhalation suspension 0.5mg
Keywords: Adult Asthmatics
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 7 days as per protocol
MAP0010 high doseDrug
a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.25mgDrug
Also called Pulmicort Respules®
a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol
Budesonide inhalation suspension 0.5mgDrug
Also called Pulmicort Respules®
a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol

Study groups in NCT00554970
Study group	Role	What they receive
Treatment 1 then Treatment 2	Other	Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol. Receives: Drug: MAP0010 low dose; Drug: Budesonide inhalation suspension 0.25mg
Treatment 2 then Treatment 1	Other	Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol. Receives: Drug: MAP0010 low dose; Drug: Budesonide inhalation suspension 0.25mg
Treatment 3 then Treatment 4	Other	Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol. Receives: Drug: MAP0010 high dose; Drug: Budesonide inhalation suspension 0.5mg
Treatment 4 then Treatment 3	Other	Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol. Receives: Drug: MAP0010 high dose; Drug: Budesonide inhalation suspension 0.5mg

What is being measured

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

Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
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: Day 1 hour 12
Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
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: Day 8 hour 12
AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Measured: Day 1 hour 12
AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Measured: Day 8 hour 12
Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
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: Day 1 hour 12
Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
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: Day 8 hour 12

Timeline

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

Nov 2007Mar 2008

First posted7 Nov 2007 (estimated)
Study startNov 2007
Primary completionJan 2008
Study completionMar 2008

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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00554970
Sponsor's protocol ID: MAP0010-CL-P202
Acronym: P202
Status last verified: Dec 2013
First submitted: 30 Oct 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?

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, Active-Controlled, 4-Treatment, 2-Period, 2 Parallel Block Crossover Pharmacokinetic and Safety Study of 2 Doses of MAP0010 in Adult Asthmatics
ClinicalTrials.gov ID: NCT00554970
Acronym / sponsor ID: P202 / MAP0010-CL-P202
Conditions: Asthma
Keywords: Adult Asthmatics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Study start: Nov 2007
Primary completion: Jan 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 7 Nov 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Treatment 1 then Treatment 2	Other	Drug: MAP0010 low dose, Drug: Budesonide inhalation suspension 0.25mgSubjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 2 then Treatment 1	Other	Drug: MAP0010 low dose, Drug: Budesonide inhalation suspension 0.25mgSubjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 3 then Treatment 4	Other	Drug: MAP0010 high dose, Drug: Budesonide inhalation suspension 0.5mgSubjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
Treatment 4 then Treatment 3	Other	Drug: MAP0010 high dose, Drug: Budesonide inhalation suspension 0.5mgSubjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female adult asthmatics with mild to moderate persistent asthma.
18 to 45 (up to the 46th birthday) years of age.
Documented diagnosis of asthma at least 3 months prior to Visit 1, per NIH/NHLBI, EPR-3 criteria.
Able to withhold short-acting bronchodilators (e.g., albuterol or ipratropium bromide) for at least 4 hours prior to clinic visits.
Baseline FEV1 greater than or equal to 50% of predicted normal.

Key exclusion criteria (3 listed)

Any other significant illness/abnormality
A history of upper or lower respiratory tract infection within 2 weeks
A history of acute or severe asthma attack requiring ICU admission or ventilatory support.

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 7 days as per protocol	Drug	Treatment 1 then Treatment 2, Treatment 2 then Treatment 1
MAP0010 high dosea single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol	Drug	Treatment 3 then Treatment 4, Treatment 4 then Treatment 3
Budesonide inhalation suspension 0.25mgAlso: Pulmicort Respules®a single dose of Pulmicort Respules® 0.25mg delivered by nebulization twice daily for 7 days as per protocol	Drug	Treatment 1 then Treatment 2, Treatment 2 then Treatment 1
Budesonide inhalation suspension 0.5mgAlso: Pulmicort Respules®a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol	Drug	Treatment 3 then Treatment 4, Treatment 4 then Treatment 3

Primary outcome

Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 1 hour 12
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).
Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 8 hour 12
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 on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 1 hour 12
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 8 hour 12
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Half-life (t1/2) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 1 hour 12
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.
Half-life (t1/2) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg
Time frame: Day 8 hour 12
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 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
Treatment 1 Then Treatment 2	8	7
Treatment 2 Then Treatment 1	8	8
Treatment 3 Then Treatment 4	8	8
Treatment 4 Then Treatment 3	8	8

Primary outcome: Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg

Time frame: Day 1 hour 12. Mean (Standard Deviation). Unit: pg/ml

Measure	MAP0010 High Dose n = 16	Pulmicort Respules® 0.50 mg n = 16	MAP0010 Low Dose n = 16	Pulmicort Respules® 0.25 mg n = 15
Value	250 (161)	365 (203)	168 (130)	197 (102)

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

Primary outcome: Cmax of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg

Time frame: Day 8 hour 12. Mean (Standard Deviation). Unit: pg/ml

Measure	MAP0010 High Dose n = 16	Pulmicort Respules® 0.50 mg n = 15	MAP0010 Low Dose n = 16	Pulmicort Respules® 0.25 mg n = 15
Value	528 (257)	530 (334)	366 (262)	315 (206)

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

Primary outcome: AUC(0-inf) of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg

Time frame: Day 1 hour 12. Mean (Standard Deviation). Unit: pg*min/ml

Measure	MAP0010 High Dose n = 14	Pulmicort Respules® 0.50 mg n = 15	MAP0010 Low Dose n = 16	Pulmicort Respules® 0.25 mg n = 13
Value	19400 (7280)	55900 (19800)	10300 (4620)	26900 (7420)

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

Primary outcome: AUC(0-inf) of Budesonide on Day 8 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg

Time frame: Day 8 hour 12. Mean (Standard Deviation). Unit: pg*min/ml

Measure	MAP0010 High Dose n = 14	Pulmicort Respules® 0.50 mg n = 14	MAP0010 Low Dose n = 16	Pulmicort Respules® 0.25 mg n = 14
Value	58700 (25700)	90100 (38200)	35500 (15000)	45200 (19500)

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
Treatment 1 Then Treatment 2	0 of 8 (0%)	7 of 8 (87.5%)	Not reported
Treatment 2, Then Treatment 1	0 of 8 (0%)	2 of 8 (25%)	Not reported
Treatment 3 Then Treatment 4	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
Treatment 4 Then Treatment 3	0 of 8 (0%)	3 of 8 (37.5%)	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.
National Institutes of HealthLink provided by the sponsor.

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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, MAP0010 high dose and Budesonide inhalation suspension 0.25mg 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 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 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. 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?

Cmax of Budesonide on Day 1 After Administration of MAP0010 Low Dose, MAP0010 High Dose, Pulmicort Respules® 0.25mg, and Pulmicort Respules® 0.5mg (time frame: Day 1 hour 12). The study lists 6 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 NCT00554970.

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; AzTrials last refreshed its copy on 8 Nov 2026.