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A 6-week Study in Asthmatic Children Aged 6 to <12 Yrs Comparing Budesonide pMDI 160ug Twice Daily With Placebo (CHASE 1)

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ClinicalTrials.gov Identifier: NCT01136382
Recruitment Status : Completed
First Posted : June 3, 2010
Results First Posted : July 21, 2014
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: budesonide
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This multicenter study was conducted in Bulgaria, Hungary, Latvia, Poland, Slovakia, South Africa, and the United States between 07 August 2011 and 05 April 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of a screening visit (Visit 1), an enrollment visit (Visit 2), a 7- to 21-day run-in/qualification period, a randomization visit (Visit 3), and 6 further weekly visits during a treatment period of 6 weeks. A telephone follow-up was conducted approximately 2 weeks after the final study visit.

Reporting Groups
  Description
Placebo Placebo pMDI bid
Budesonide Budesonide pMDI 160 mcg bid

Participant Flow:   Overall Study
    Placebo   Budesonide
STARTED   152   152 
COMPLETED   92   121 
NOT COMPLETED   60   31 
Not Specified                8                3 
Study-Specific Withdrawal Criteria                48                25 
Severe Non-Compliance to Protocol                0                2 
Withdrawal by Subject                4                1 



  Baseline Characteristics

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
Placebo Placebo pMDI bid
Budesonide Budesonide pMDI 160 mcg bid
Total Total of all reporting groups

Baseline Measures
   Placebo   Budesonide   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   152   304 
Age 
[Units: Years]
Mean (Standard Deviation)
 9.0  (1.62)   9.0  (1.63)   9.0  (1.62) 
Age, Customized 
[Units: Participants]
     
6 to <8 years   33   33   66 
8 to- <12 years   119   119   238 
Gender 
[Units: Participants]
     
Female   58   54   112 
Male   94   98   192 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   10   11   21 
Native Hawaiian/Pacific Islander   1   0   1 
African American   7   9   16 
Asian (other than Chinese and Japanese)   0   2   2 
Not Applicable   128   126   254 
Other   6   4   10 
Forced expiratory volume in 1 second (FEV1) 
[Units: Liters]
Mean (Standard Deviation)
 1.70  (0.416)   1.69  (0.388)   1.70  (0.401) 


  Outcome Measures

1.  Primary:   Change in Morning Peak Expiratory Flow (PEF) From Baseline to the Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

2.  Secondary:   Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

3.  Secondary:   Change in Evening PEF From Baseline to the Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

4.  Secondary:   Change in Forced Vital Capacity (FVC) From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

5.  Secondary:   Change in Forced Mid-expiratory Flow Between 25% and 75% of the FVC (FEF25-75) From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

6.  Secondary:   Change in Total Daily and Daytime Asthma Symptom Scores From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

7.  Secondary:   Change in Nighttime Asthma Symptom Score From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

8.  Secondary:   Change in Nighttime Awakenings and Nighttime Awakenings With Reliever Medication Use From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

9.  Secondary:   Change in Total Daily and Daytime Reliever Medication Use From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

10.  Secondary:   Change in Nighttime Reliever Medication Use From Baseline to Treatment Period Average   [ Time Frame: Baseline to 6 weeks ]

11.  Secondary:   Number of Withdrawals Due to Pre-defined Asthma Events   [ Time Frame: Baseline to 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Geoff Gilmartin
Organization: AstraZeneca
e-mail: ClinicalTrialTransparency@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01136382     History of Changes
Other Study ID Numbers: D589GC00001
First Submitted: June 1, 2010
First Posted: June 3, 2010
Results First Submitted: March 25, 2014
Results First Posted: July 21, 2014
Last Update Posted: August 1, 2014