Tolerability and PK of Submicron Budesonide in Children 4 to 11 Years Old With Mild-To-Moderate Stable Asthma

This study has been completed.
Sponsor:
Collaborator:
MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00995904
First received: October 6, 2009
Last updated: December 9, 2013
Last verified: December 2013
Results First Received: April 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: 84ug MAP0020
Drug: 42ug MAP0020
Drug: 21ug MAP0020

  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
This is a 3-treatment, 3-period, 6-sequence crossover study. Each subject received all 3 treatments in a randomly assigned order: treatments A, B, and C, the sequences were ABC, ACB, BAC, BCA, CAB, and CBA.

Reporting Groups
  Description
Treatment A, Then Treatment B, Then Treatment C Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment A, Then Treatment C, Then Treatment B Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment B, Then Treatment A, Then Treatment C Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment B, Then Treatment C, Then Treatment A Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment C, Then Treatment A, Then Treatment B Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
Treatment C, Then Treatment B, Then Treatment A Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4

Participant Flow for 4 periods

Period 1:   Visit 2 (Randomization)
    Treatment A, Then Treatment B, Then Treatment C     Treatment A, Then Treatment C, Then Treatment B     Treatment B, Then Treatment A, Then Treatment C     Treatment B, Then Treatment C, Then Treatment A     Treatment C, Then Treatment A, Then Treatment B     Treatment C, Then Treatment B, Then Treatment A  
STARTED     4     3     4     5     5     4  
COMPLETED     4     3     4     5     5     4  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Visit 3
    Treatment A, Then Treatment B, Then Treatment C     Treatment A, Then Treatment C, Then Treatment B     Treatment B, Then Treatment A, Then Treatment C     Treatment B, Then Treatment C, Then Treatment A     Treatment C, Then Treatment A, Then Treatment B     Treatment C, Then Treatment B, Then Treatment A  
STARTED     4     3     4     5     5     3 [1]
COMPLETED     4     3     4     5     5     3  
NOT COMPLETED     0     0     0     0     0     0  
[1] One subject was withdrawn from the study after completion of Visit 2 but prior to Visit 3.

Period 3:   Visit 4
    Treatment A, Then Treatment B, Then Treatment C     Treatment A, Then Treatment C, Then Treatment B     Treatment B, Then Treatment A, Then Treatment C     Treatment B, Then Treatment C, Then Treatment A     Treatment C, Then Treatment A, Then Treatment B     Treatment C, Then Treatment B, Then Treatment A  
STARTED     4     3     4     5     5     3  
COMPLETED     4     3     4     5     5     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 4:   Follow-up Visit (Final Visit)
    Treatment A, Then Treatment B, Then Treatment C     Treatment A, Then Treatment C, Then Treatment B     Treatment B, Then Treatment A, Then Treatment C     Treatment B, Then Treatment C, Then Treatment A     Treatment C, Then Treatment A, Then Treatment B     Treatment C, Then Treatment B, Then Treatment A  
STARTED     4     3     4     5     5     3  
COMPLETED     4     3     4     5     5     3  
NOT COMPLETED     0     0     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]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  8.3  ± 1.88  
Gender  
[units: participants]
 
Female     11  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax of Budesonide After Administration of MAP0020   [ Time Frame: 12 hours ]

2.  Primary:   AUC(0-inf) of Budesonide After Administration of MAP0020   [ Time Frame: 12 hours ]

3.  Primary:   Half-life (t1/2) of Budesonide After Administration of MAP0020   [ Time Frame: 12 hours ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


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: NCT00995904     History of Changes
Other Study ID Numbers: MAP0020-CL-P201
Study First Received: October 6, 2009
Results First Received: April 17, 2013
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration