AsthmaPhase 1UDB P101NCT00627679

Safety and Blood Level Study of Unit Dose Budesonide

A Phase 1 study testing Budesonide Inhalation Suspension, MAP0010 low dose and MAP0010 intermediate dose in people with Asthma, run by Allergan at 1 site in Australia.

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 evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Asthma
What is being tested?: Budesonide Inhalation Suspension, MAP0010 low dose and MAP0010 intermediate dose
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteAustralia
Study dates: Dec 2005to May 2006
Phase: Phase 1
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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult volunteers, aged 18-50 years
BMI less than 30 kg/m2
Non smoker (currently and <10 pack years total if ex-smoker)

Who cannot join

Any use of corticosteroid in previous 4 weeks
Pregnancy/lactation
Significant blood donation (or testing) in previous 8 weeks

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q-Pharm Pty Limited
Brisbane, Queensland, QLD 4006

Other trials in Australia

About this study

Official title: A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Conditions: Asthma
Being tested: Budesonide Inhalation Suspension, MAP0010 low dose, MAP0010 intermediate dose, MAP0010 high dose
Keywords: Pediatric asthma
Medical subject headings: Asthma

What participants receive

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

Budesonide Inhalation SuspensionDrug
Also called Pulmicort Respules®
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
MAP0010 low doseDrug
Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
MAP0010 intermediate doseDrug
Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
MAP0010 high doseDrug
Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Study groups in NCT00627679
Study group	Role	What they receive
Treatment sequence: A, B, D, C	Experimental	Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5 Receives: Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose
Treatment sequence: B, C, A, D	Experimental	Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5 Receives: Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose
Treatment sequence: C, D, B, A	Experimental	Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5 Receives: Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose
Treatment sequence: D, A, C, B	Experimental	Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5 Receives: Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

What is being measured

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

Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
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: 8 hours
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
Measured: 8 hours
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).
Measured: 8 hours
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg*min/ml).
Measured: 8 hours
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
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 (min).
Measured: 8 hours

Timeline

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

Dec 2005May 2006

First posted3 Mar 2008 (estimated)
Study startDec 2005
Primary completionDec 2005
Study completionMay 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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00627679
Sponsor's protocol ID: MAP0010-CL-P101
Acronym: UDB P101
Status last verified: Dec 2013
First submitted: 22 Feb 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, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010
ClinicalTrials.gov ID: NCT00627679
Acronym / sponsor ID: UDB P101 / MAP0010-CL-P101
Conditions: Asthma
Keywords: Pediatric asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Collaborators: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan, Q-Pharm Pty Limited
Study start: Dec 2005
Primary completion: Dec 2005 (actual)
Study completion: May 2006 (actual)
First posted: 3 Mar 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 purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment sequence: A, B, D, C	Experimental	Drug: Budesonide Inhalation Suspension, Drug: MAP0010 low dose, Drug: MAP0010 intermediate dose, Drug: MAP0010 high doseTreatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5
Treatment sequence: B, C, A, D	Experimental	Drug: Budesonide Inhalation Suspension, Drug: MAP0010 low dose, Drug: MAP0010 intermediate dose, Drug: MAP0010 high doseTreatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
Treatment sequence: C, D, B, A	Experimental	Drug: Budesonide Inhalation Suspension, Drug: MAP0010 low dose, Drug: MAP0010 intermediate dose, Drug: MAP0010 high doseTreatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5
Treatment sequence: D, A, C, B	Experimental	Drug: Budesonide Inhalation Suspension, Drug: MAP0010 low dose, Drug: MAP0010 intermediate dose, Drug: MAP0010 high doseTreatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Healthy adult volunteers, aged 18-50 years
BMI less than 30 kg/m2
Non smoker (currently and <10 pack years total if ex-smoker)

Key exclusion criteria (3 listed)

Any use of corticosteroid in previous 4 weeks
Pregnancy/lactation
Significant blood donation (or testing) in previous 8 weeks

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
Budesonide Inhalation SuspensionAlso: Pulmicort Respules®Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.	Drug	Treatment sequence: A, B, D, C, Treatment sequence: B, C, A, D, Treatment sequence: C, D, B, A, Treatment sequence: D, A, C, B
MAP0010 low doseTreatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.	Drug	Treatment sequence: A, B, D, C, Treatment sequence: B, C, A, D, Treatment sequence: C, D, B, A, Treatment sequence: D, A, C, B
MAP0010 intermediate doseTreatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.	Drug	Treatment sequence: A, B, D, C, Treatment sequence: B, C, A, D, Treatment sequence: C, D, B, A, Treatment sequence: D, A, C, B
MAP0010 high doseTreatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.	Drug	Treatment sequence: A, B, D, C, Treatment sequence: B, C, A, D, Treatment sequence: C, D, B, A, Treatment sequence: D, A, C, B

Primary outcome

Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
Time frame: 8 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).
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Time frame: 8 hours
Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
Time frame: 8 hours
The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg*min/ml).
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Time frame: 8 hours
The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) 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 Pulmicort Respules® and Three Dose Levels of MAP0010
Time frame: 8 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 (min).

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 A, B, D, C	4	4
Treatment B, C, A, D	4	4
Treatment C, D, B, A	4	4
Treatment D, A, C, B	4	4

Primary outcome: Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010

Time frame: 8 hours. Mean (Standard Deviation). Unit: pg/mL

Measure	Treatment A n = 16	Treatment B n = 15	Treatment C n = 16	Treatment D n = 16
Value	303.5 (177.4)	106.2 (63.47)	239.9 (140.1)	434.5 (246.9)

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

Primary outcome: Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010

Time frame: 8 hours. Mean (Standard Deviation). Unit: min

Measure	Treatment A n = 16	Treatment B n = 15	Treatment C n = 16	Treatment D n = 16
Value	9.063 (7.122)	4.467 (3.270)	3.125 (1.500)	3.688 (1.448)

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

Primary outcome: AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010

Time frame: 8 hours. Mean (Standard Deviation). Unit: pg*min/mL

Measure	Treatment A n = 16	Treatment B n = 15	Treatment C n = 16	Treatment D n = 16
Value	29040 (9316)	3978 (1974)	8626 (4184)	22130 (9675)

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 Pulmicort Respules® and Three Dose Levels of MAP0010

Time frame: 8 hours. Mean (Standard Deviation). Unit: pg*min/mL

Measure	Treatment A n = 16	Treatment B n = 12	Treatment C n = 13	Treatment D n = 14
Value	31480 (10690)	4391 (1423)	7842 (3647)	25290 (11750)

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 A	0 of 16 (0%)	4 of 16 (25%)	Not reported
Treatment B	0 of 16 (0%)	4 of 16 (25%)	Not reported
Treatment C	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
Treatment D	0 of 16 (0%)	3 of 16 (18.8%)	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.

Joanne Marjason, MBBS principal investigator

Q-Pharm Pty Limited

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Budesonide Inhalation Suspension, MAP0010 low dose and MAP0010 intermediate dose in people with Asthma, run by Allergan at 1 site in Australia.

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 3 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 Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010 (time frame: 8 hours). The study lists 5 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 NCT00627679.

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.