Response to Albuterol Delivered Through an Anti-static Valved Holding Chamber During Nocturnal Bronchospasm

This study has been completed.
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01111110
First received: April 23, 2010
Last updated: May 14, 2012
Last verified: May 2012
Results First Received: January 10, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Device: anti-static then static
Device: Static then anti-static chamber

  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
Recruitment process was done in the Asthma Research Lab. Note that 88 were screened and 4 subjects randomized but determined to be ineligile before starting treatment. They are amongst the screen failures.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects qualified in the screening visit went into a 7 day run-in-period They needed to have a 20% peak flow overnight drop on 3/7 nights in order to qualify for overnight stays in the Clinical Research Center. Arms are identified by order of treatment assignment. Any other designation is not consistent with our protocol requirements.

Reporting Groups
  Description
Anti-static/Static albuterol with anti-static chamber then Static on another night
Static/Antistatic albuterol with static chamber then with antistatic chamber on another night.

Participant Flow:   Overall Study
    Anti-static/Static     Static/Antistatic  
STARTED     3     4  
COMPLETED     3     4  
NOT COMPLETED     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
Anti-static/Static albuterol with anti-static chamber then Static on another night
Static/Antistatic albuterol with static chamber then with antistatic chamber on another night.
Total Total of all reporting groups

Baseline Measures
    Anti-static/Static     Static/Antistatic     Total  
Number of Participants  
[units: participants]
  3     4     7  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     4     7  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  28.3  ± 11.1     21.5  ± 2.8     24.4  ± 7.2  
Gender  
[units: participants]
     
Female     1     3     4  
Male     2     1     3  
Region of Enrollment  
[units: participants]
     
United States     3     4     7  



  Outcome Measures
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1.  Primary:   Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.   [ Time Frame: fifteen minutes after 1 puff of albuterol ]

2.  Primary:   Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.   [ Time Frame: 15 minutes after 2 puffs of albuterol ]

3.  Primary:   Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.   [ Time Frame: fifteen minutes after 4 puffs of albuterol ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
Nocturnal asthma model is a very sensitive model, but very labor intensive and to get more completed subjects, we might need to do multicenter trial  


Results Point of Contact:  
Name/Title: Dr.Sreekala Prabhakaran. Clinical Assistant Professor Pediatrics
Organization: University of Florida
phone: 352-273-8381
e-mail: sprabhakaran@peds.ufl.edu


No publications provided


Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01111110     History of Changes
Other Study ID Numbers: IRB 103-2008, Children's Miracle Network UFl
Study First Received: April 23, 2010
Results First Received: January 10, 2012
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board