Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01111110
Recruitment Status : Completed
First Posted : April 27, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Collaborator:
Children's Miracle Network
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Device: anti-static then static
Device: Static then anti-static chamber
Enrollment 88
Recruitment Details 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 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.
Arm/Group Title Anti-static/Static Static/Antistatic
Hide Arm/Group Description albuterol with anti-static chamber then Static on another night albuterol with static chamber then with antistatic chamber on another night.
Period Title: Overall Study
Started 3 4
Completed 3 4
Not Completed 0 0
Arm/Group Title Anti-static/Static Static/Antistatic Total
Hide Arm/Group Description albuterol with anti-static chamber then Static on another night albuterol with static chamber then with antistatic chamber on another night. Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
 100.0%
4
 100.0%
7
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 7 participants
28.3  (11.1) 21.5  (2.8) 24.4  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
1
  33.3%
3
  75.0%
4
  57.1%
Male
2
  66.7%
1
  25.0%
3
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 4 participants 7 participants
3 4 7
1.Primary Outcome
Title Y=100([FEV1 at 1 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Hide Description (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 1 Puff go into chamber
Time Frame fifteen minutes after 1 puff of albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
Arm/Group Title Anti-static/Static Static/Antistatic
Hide Arm/Group Description:
albuterol with anti-static chamber then Static on another night
albuterol with static chamber then with antistatic chamber on another night.
Overall Number of Participants Analyzed 3 4
Mean (Standard Error)
Unit of Measure: Diff in % change from 4AM
-15.4  (12.2) 26.7  (20.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-static/Static, Static/Antistatic
Comments (Comparison of period 2 minus period 1) results Point and interval estimates are halved because this estimates twice the effect size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method t-test, 2 sided
Comments two sample effect size must be halved to account for mean difference estimates twice the effect size
Method of Estimation Estimation Parameter half the mean difference
Estimated Value 21.0
Confidence Interval (2-Sided) 95%
3.8 to 41.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.7
Estimation Comments See 4 Puff result
2.Primary Outcome
Title Y=100([FEV1 at 2 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Hide Description (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value) less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 2 Puffs go into chamber
Time Frame 15 minutes after 2 puffs of albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
Arm/Group Title Anti-static/Static Static/Antistatic
Hide Arm/Group Description:
albuterol with anti-static chamber then Static on another night
albuterol with static chamber then with antistatic chamber on another night.
Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: Diff in % change from 4AM
-15.3  (14.1) 31.8  (19.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-static/Static, Static/Antistatic
Comments Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments The effect size is half the difference between the means as (A-B)-(B-A)=2A-2B
Method t-test, 2 sided
Comments Must take half the mean difference to estimate effect size
Method of Estimation Estimation Parameter half the mean difference
Estimated Value 23.5
Confidence Interval (2-Sided) 95%
6.0 to 41.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.8
Estimation Comments No comments
3.Primary Outcome
Title Y=100([FEV1 at 4 Puffs-FEV1 at 4AM)/FEV1@4AM] Difference Period 2 Minus Period 1.
Hide Description (Percent improvement in FEV1 Post Dose for Period 2 over 4AM Baseline value)less (Percent improvement in FEV1 Post Dose for Period 1 over 4AM Baseline value) when 4 Puffs go into chamber
Time Frame fifteen minutes after 4 puffs of albuterol
Hide Outcome Measure Data
Hide Analysis Population Description
Study intended to get more subjects, but PI's review committee had to deal with candidate deadlines and a high rate of screen failures and allowed her to test seven subjects. Primary concern was the research experience, not the study questions. There was no bias in failing to meet accrual objectives thanks to the blinding.
Arm/Group Title Anti-static/Static Static/Antistatic
Hide Arm/Group Description:
albuterol with anti-static chamber then Static on another night
albuterol with static chamber then with antistatic chamber on another night.
Overall Number of Participants Analyzed 3 4
Mean (Standard Deviation)
Unit of Measure: Diff in % change from 4AM
-17.5  (13.6) 31.9  (19.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Anti-static/Static, Static/Antistatic
Comments Null hypothesis is that the Treatment order is independent of the dependent variable based on Period 2 minus Period 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Effect size=half the mean diff
Estimated Value 24.7
Confidence Interval (2-Sided) 95%
7.7 to 41.7
Parameter Dispersion
Type: Standard Error of the mean
Value: 6.6
Estimation Comments You kicked this out on another trial, but note that the period 2-Period 1 differences between the orderings estimate twice the effect size. The effect sizes herein take this into account.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Static Antistatic
Hide Arm/Group Description albuterol with static chamber albuterol with antistatic chamber.
All-Cause Mortality
Static Antistatic
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Static Antistatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Static Antistatic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%) 
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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Sreekala Prabhakaran. Clinical Assistant Professor Pediatrics
Organization: University of Florida
Phone: 352-273-8381
EMail: sprabhakaran@peds.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01111110     History of Changes
Other Study ID Numbers: IRB 103-2008
Children's Miracle Network UFl ( Other Grant/Funding Number: Children's Miracle Network, University of Florida )
First Submitted: April 23, 2010
First Posted: April 27, 2010
Results First Submitted: January 10, 2012
Results First Posted: June 19, 2012
Last Update Posted: June 19, 2012