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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00627679
Registration number
NCT00627679
Ethics application status
Date submitted
22/02/2008
Date registered
3/03/2008
Date last updated
9/01/2014
Titles & IDs
Public title
Safety and Blood Level Study of Unit Dose Budesonide
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Scientific title
A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010
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Secondary ID [1]
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MAP0010-CL-P101
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Universal Trial Number (UTN)
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Trial acronym
UDB P101
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Budesonide Inhalation Suspension
Treatment: Drugs - MAP0010 low dose
Treatment: Drugs - MAP0010 intermediate dose
Treatment: Drugs - MAP0010 high dose
Experimental: Treatment sequence: A, B, D, C - 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
Experimental: Treatment sequence: B, C, A, D - 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
Experimental: Treatment sequence: C, D, B, A - 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
Experimental: Treatment sequence: D, A, C, B - 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
Treatment: Drugs: Budesonide Inhalation Suspension
Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.
Treatment: Drugs: MAP0010 low dose
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.
Treatment: Drugs: MAP0010 intermediate dose
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.
Treatment: Drugs: MAP0010 high dose
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
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Assessment method [1]
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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).
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Timepoint [1]
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8 hours
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Primary outcome [2]
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Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
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Assessment method [2]
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Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).
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Timepoint [2]
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8 hours
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Primary outcome [3]
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AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
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Assessment method [3]
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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).
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Timepoint [3]
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8 hours
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Primary outcome [4]
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AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
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Assessment method [4]
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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).
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Timepoint [4]
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8 hours
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Primary outcome [5]
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Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
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Assessment method [5]
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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).
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Timepoint [5]
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8 hours
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Eligibility
Key inclusion criteria
- Healthy adult volunteers, aged 18-50 years
- BMI less than 30 kg/m2
- Non smoker (currently and <10 pack years total if ex-smoker)
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Any use of corticosteroid in previous 4 weeks
- Pregnancy/lactation
- Significant blood donation (or testing) in previous 8 weeks
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2006
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Sample size
Target
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Accrual to date
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Final
16
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Q-Pharm Pty Limited - Brisbane
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Recruitment postcode(s) [1]
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QLD 4006 - Brisbane
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Allergan
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
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Address [1]
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Country [1]
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Other collaborator category [2]
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Commercial sector/Industry
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Name [2]
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Q-Pharm Pty Limited
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00627679
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Joanne Marjason, MBBS
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Address
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Q-Pharm Pty Limited
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00627679
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