Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Trial website
https://clinicaltrials.gov/study/NCT00627679
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00627679