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Trial record 25 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations

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ClinicalTrials.gov Identifier: NCT01218399
Recruitment Status : Completed
First Posted : October 11, 2010
Results First Posted : August 18, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Kari Christine Nadeau, Stanford University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Asthma
Intervention Drug: Symbicort
Enrollment 10
Recruitment Details  
Pre-assignment Details Participants that contract a viral upper respiratory illness which induces an asthma exacerbation and meets eligibility criteria will be randomized at Day 1 to either Symbicort or Budesonide in a 1:1 randomization. 5 participants were randomly assigned to the Symbicort study arm, and 5 participants were assigned to the Budesonide study arm.
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description

Combination of budesonide and formoterol

Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)

Control of budesonide alone

Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)

Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Symbicort Budesonide Total
Hide Arm/Group Description

combination of budesonide and formoterol

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

control of budesonide alone

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
 100.0%
5
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
24  (5) 25  (6) 24  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
2
  40.0%
3
  60.0%
5
  50.0%
Male
3
  60.0%
2
  40.0%
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 10 participants
5 5 10
1.Primary Outcome
Title Percent Forced Expiratory Volume in One Second (FEV1)
Hide Description

Asthma symptoms scores reported as measure of FEV1 - Forced Expiratory Volume in one second

  • FEV1 is given which is a standard outcome in asthma studies and is validated by the NIH (NHLBI)
  • FEV1 of less than 80 is indicative of severe asthma, 80-90 is moderate asthma, over 90 is mild asthma

http://www.med.umich.edu/1info/FHP/practiceguides/asthma/EPR-3_pocket_guide.pdf

Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:

combination of budesonide and formoterol

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

control of budesonide alone

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: % FEV1
90  (13) 88  (14)
2.Secondary Outcome
Title Adverse Events
Hide Description Number of adverse events as per MEDRA terms
Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description:

combination of budesonide and formoterol

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

control of budesonide alone

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: Number adverse events
0 0
Time Frame Data was collected for a year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Symbicort Budesonide
Hide Arm/Group Description

combination of budesonide and formoterol

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

control of budesonide alone

Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide

All-Cause Mortality
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Symbicort Budesonide
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
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.
Please contact the sponsor Astra Zeneca for the agreement
Results Point of Contact
Name/Title: Elena Pizzi
Organization: Astra Zeneca
Phone: +1 302 885 2677
Responsible Party: Kari Christine Nadeau, Stanford University
ClinicalTrials.gov Identifier: NCT01218399     History of Changes
Other Study ID Numbers: SU-10042010-7010
IRB 15128
First Submitted: October 7, 2010
First Posted: October 11, 2010
Results First Submitted: January 23, 2015
Results First Posted: August 18, 2017
Last Update Posted: August 18, 2017