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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
Secondary ID [1] 0 0
MAP0010-CL-P101
Universal Trial Number (UTN)
Trial acronym
UDB P101
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Asthma

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
Timepoint [1] 0 0
8 hours
Primary outcome [2] 0 0
Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Timepoint [2] 0 0
8 hours
Primary outcome [3] 0 0
AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
Timepoint [3] 0 0
8 hours
Primary outcome [4] 0 0
AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Timepoint [4] 0 0
8 hours
Primary outcome [5] 0 0
Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
Timepoint [5] 0 0
8 hours

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)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Any use of corticosteroid in previous 4 weeks
* Pregnancy/lactation
* Significant blood donation (or testing) in previous 8 weeks

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Limited - Brisbane
Recruitment postcode(s) [1] 0 0
QLD 4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Q-Pharm Pty Limited
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Marjason, MBBS
Address 0 0
Q-Pharm Pty Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00627679