Safety and Blood Level Study of Unit Dose Budesonide (UDB P101)

This study has been completed.
Sponsor:
Collaborators:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Q-Pharm Pty Limited
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00627679
First received: February 22, 2008
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: August 19, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Budesonide Inhalation Suspension
Drug: MAP0010 low dose
Drug: MAP0010 intermediate dose
Drug: MAP0010 high dose

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

All subjects received all 4 treatments in a randomly assigned order. The treatments were:

Treatment A: Pulmicort Respules® Treatment B: MAP0010 low dose Treatment C: MAP0010 intermediate dose Treatment D: MAP0010 high dose The sequences were Treatments ABDC, BACD, CDBA, DACB.


Reporting Groups
  Description
Treatment A, B, D, C Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of 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 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 Pulmicort Respules® delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5
Treatment 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 Pulmicort Respules® delivered by nebulization at Visit 5
Treatment 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 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

Participant Flow:   Overall Study
    Treatment A, B, D, C     Treatment B, C, A, D     Treatment C, D, B, A     Treatment D, A, C, B  
STARTED     4     4     4     4  
COMPLETED     4     4     4     4  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Patients All patients that were enrolled in the study.

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  16  
Age  
[units: years]
Mean ± Standard Deviation
  23.3  ± 4.3  
Gender  
[units: participants]
 
Female     8  
Male     8  



  Outcome Measures
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1.  Primary:   Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010   [ Time Frame: 8 hours ]

2.  Primary:   Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010   [ Time Frame: 8 hours ]

3.  Primary:   AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010   [ Time Frame: 8 hours ]

4.  Primary:   AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010   [ Time Frame: 8 hours ]

5.  Primary:   Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010   [ Time Frame: 8 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: VP, Scientific Affairs
Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan
phone: (650) 386-3100
e-mail: dkellerman@mappharma.com


No publications provided


Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00627679     History of Changes
Other Study ID Numbers: MAP0010-CL-P101
Study First Received: February 22, 2008
Results First Received: August 19, 2013
Last Updated: December 9, 2013
Health Authority: Australia: Therapeutic Goods Administration