Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01070888
• Collaborator: Brigham and Women's Hospital (Other)
• Enrollment: 6
• Locations: 2
• Arms: 2
• Duration (Months): 49.9
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

Condition or Disease	Intervention/Treatment	Phase
Exercise Induced Asthma	Drug: Budesonide/Formoterol; Drug: Budesonide	Phase 4

Detailed Description

The purpose of this study is to find out if Symbicort® (budesonide/formoterol), a new combination asthma medication, is more effective than budesonide alone in controlling exercise induced asthma.

The investigators hypothesize that in children and adults who suffer from asthma and exercise induced asthma there will be less decline in lung function associated with exercise when they receive the study medication.

40 subjects will be randomized to receive both active medications in separate testing periods to determine the effect on their lung function after exercise testing.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Double Dummy Crossover Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma in Patients With Persistent Asthma
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Budesonide/Formoterol first This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide and dummy inhaler.	Drug: Budesonide/Formoterol; Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks; Other Names: Symbicort ; Drug: Budesonide; Budesonide 180mcg, 2 puffs twice daily for 2 weeks; Other Names: Pulmicort
Active Comparator: Budesonide first This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. The second study period will be budesonide/formoterol and dummy inhaler.	Drug: Budesonide/Formoterol; Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks; Other Names: Symbicort ; Drug: Budesonide; Budesonide 180mcg, 2 puffs twice daily for 2 weeks; Other Names: Pulmicort

Outcome Measures

Primary Outcome Measures

1. Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide [8 weeks]

   Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female Patients aged 12 to 50 years with a diagnosis of asthma for at least 6 months before screening

• Baseline FEV1 of 60% to >100% of predicted

• Demonstrate a decrease in FEV1 of 15% or greater from baseline after standardized stepped exercise challenge testing

• Taking a constant dose of low-medium dose inhaled steroids for at least 30 days before screening of either:

1. fluticasone, 88 - 440 mcg/d via MDI or 100 to 500 mcg/d via DPI

2. beclomethasone HFA 80 to 480 mcg/day

3. budesonide DPI 180 to 1200 mcg/ d

4. flunisolide 500 to 2000 mcg/d

5. flunisolide HFA 320 to 640 mcg/d

6. mometasone 200 to 800 mcg/d

7. triamcinolone acetonide 300 to 1500 mcg/ d

Exclusion Criteria:

• Patients already on LABAs, systemic corticosteroids, or other combination inhaled steroids/LABA medications.

• Patients not able to safely complete an exercise challenge due to physical constraints outside of their respiratory status.

• Patients who are pregnant or plan to become pregnant during the study period.

• Patients with a history of hypersensitivity reaction to either formoterol or budesonide.

• Patients with any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.

• Patients with planned hospitalization during the study

• Current Smokers or those with a history of 10 pack years of tobacco use or more.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
2	Children's Hospital Boston	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Boston Children's Hospital
• Brigham and Women's Hospital

Investigators

• Principal Investigator: Wanda Phipatanakul, MD,MS, Boston Children's Hospital
• Study Director: Jonathan M Gaffin, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wanda Phipatanakul, Study PI, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01070888
• Other Study ID Numbers: 08080372
• First Posted: Feb 18, 2010
• Last Update Posted: Jul 7, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Wanda Phipatanakul, Study PI, Boston Children's Hospital: Asthma; Exercise Induced Asthma
• Additional relevant MeSH terms: Asthma; Asthma, Exercise-Induced; Budesonide; Formoterol Fumarate

Study Results

Participant Flow

Recruitment Details	October 2010 to October 2012
Pre-assignment Detail	excluded from failed run-in or not qualify by exercise challenge

Arm/Group Title	Budesonide First	Budesonide/Formoterol First
Arm/Group Description	This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily. Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks	This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Period Title: First Intervention (14 Days)
STARTED	2	4
COMPLETED	2	2
NOT COMPLETED	0	2
Period Title: First Intervention (14 Days)
STARTED	2	2
COMPLETED	1	2
NOT COMPLETED	1	0
Period Title: First Intervention (14 Days)
STARTED	1	2
COMPLETED	1	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Budesonide First	Budesonide/Formoterol First	Total
Arm/Group Description	This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks	This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,	Total of all reporting groups
Overall Participants	2	4	6
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	29.5	22.5	24.8
Sex: Female, Male (Count of Participants)
Female	2 100%	2 50%	4 66.7%
Male	0 0%	2 50%	2 33.3%
FEV1 fall % predicted with exercise (percent fall in FEV1) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percent fall in FEV1]	15.5 (0.6)	61.1 (13.0)	45.9 (25.6)

Outcome Measures

1. Primary Outcome

Title	Mean Difference Between Maximal Percentage Decrease in FEV1 After the Exercise Challenge Compared to the Run in Period, Budesonide/Formoterol - Budesonide
Description	Mean difference between maximal percentage decrease in FEV1 after the exercise challenge compared to the run in period, budesonide/formoterol - budesonide, calculated as follows: (max fall in FEV1(baseline) - maximal fall in FEV1(bud/form) - (max fall in FEV1(baseline) - maximal fall in FEV1(bud))
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Budesonide First	Budesonide/Formoterol First
Arm/Group Description	This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks	This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily. Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
Measure Participants	1	2
Mean (Standard Deviation) [percentage of fall in FEV1]	-3.1 (0)	-19.4 (30.5)

Adverse Events

Time Frame	Throughout entire study, 2 years
Arm/Group Title	Budesonide/Formoterol		Budesonide
Arm/Group Description	This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks		This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks
All Cause Mortality
	Budesonide/Formoterol		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Budesonide/Formoterol		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Budesonide/Formoterol		Budesonide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		0/4 (0%)
Respiratory, thoracic and mediastinal disorders
asthma exacerbation	1/5 (20%)	1	0/4 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT 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.