Trial Outcomes & Findings for Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations (NCT NCT01218399)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

1 week

Results posted on

2017-08-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Symbicort Combination of budesonide and formoterol Symbicort will be given as per product insert (2 puffs twice daily of 160/4.5 Budesonide/formoterol)	Budesonide Control of budesonide alone Pulmicort Flexhaler will be given as per product insert (2 puffs twice daily of 160 mcg)
Overall Study STARTED	5	5
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Symbicort n=5 Participants combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	Budesonide n=5 Participants control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24 years STANDARD_DEVIATION 5 • n=5 Participants	25 years STANDARD_DEVIATION 6 • n=7 Participants	24 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	Symbicort n=5 Participants combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	Budesonide n=5 Participants control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide
Percent Forced Expiratory Volume in One Second (FEV1)	90 % FEV1 Standard Deviation 13	88 % FEV1 Standard Deviation 14

SECONDARY outcome

Timeframe: 1 week

Number of adverse events as per MEDRA terms

Outcome measures

Outcome measures
Measure	Symbicort n=5 Participants combination of budesonide and formoterol Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide	Budesonide n=5 Participants control of budesonide alone Symbicort vs Budesonide in treating acute respiratory illness: use of either symbicort or budesonide
Adverse Events	0 Number adverse events	0 Number adverse events

Adverse Events

Symbicort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elena Pizzi

Astra Zeneca

Phone: +1 302 885 2677

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact the sponsor Astra Zeneca for the agreement
Publication restrictions are in place

Restriction type: OTHER