Trial on the Effect of Budesonide/Formoterol and Inhaled Budesonide Alone on Exercise-Induced Asthma
NCT01070888 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2021-07-07
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.
Conditions
- Exercise Induced Asthma
Interventions
- DRUG
-
Budesonide/Formoterol
Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
- DRUG
-
Budesonide
Budesonide 180mcg, 2 puffs twice daily for 2 weeks
Sponsors & Collaborators
-
Brigham and Women's Hospital
collaborator OTHER - lead OTHER
Principal Investigators
-
Wanda Phipatanakul, MD,MS · Boston Children's Hospital
-
Jonathan M Gaffin, MD · Boston Children's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 12 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2014-04-30
- Completion
- 2014-04-30
Countries
- United States
Study Locations
More Related Trials
-
Randomized, Placebo-Controlled, Multidose, Study Comparing Generic Budesonide/Formoterol Fumarate Dihydrate to Symbicort® in Asthmatic Participants
NCT02495168 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
NCT00989833 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy of Symbicort pMDI Administered Once Daily in Adolescents and Adults During 12 Weeks - STEM
NCT00652392 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
NCT02224157 ·Status: COMPLETED ·Phase: PHASE3
-
Use of Symbicort or Pulmicort to Treat Viral-mediated Asthma Exacerbations
NCT01218399 ·Status: COMPLETED ·Phase: NA
-
Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
NCT01676987 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Budesonide / Formoterol Combination in Repeated AMP Provocations
NCT00272753 ·Status: COMPLETED ·Phase: PHASE4
-
Phase4/Symbicort® Versus Pulmicort Flexhaler® in African Americans
NCT00702325 ·Status: COMPLETED ·Phase: PHASE4
-
New Breath Actuated MDI Symbicort Compared to Symbicort pMDI and Budesonide pMDI for 12 Weeks Twice a Day
NCT01360021 ·Status: COMPLETED ·Phase: PHASE3
-
Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler
NCT00658255 ·Status: COMPLETED ·Phase: PHASE2
-
SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
NCT00238784 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma.
NCT02149199 ·Status: COMPLETED ·Phase: PHASE3
-
A Non-inferiority Study to Evaluate Efficacy, Safety and Tolerability of NEUMOTEROL® 400 and SYMBICORT® Forte in Adults With Asthma
NCT02233803 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT
NCT00646321 ·Status: COMPLETED ·Phase: PHASE3
-
Effects of Budesonide & Budesonide/Formoterol on Smoking Asthmatic Subjects
NCT00691951 ·Status: COMPLETED ·Phase: PHASE3
-
Study of Preventive Treatment With Symbicort or Budicort Turbohaler in Childhood Asthma Return to School Epidemic
NCT01179152 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Safety and Efficacy of Symbicort® pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma
NCT00536913 ·Status: COMPLETED ·Phase: PHASE3
-
An Efficacy Study Comparing SYMBICORT® Pressurised Metered Dose Inhaler (pMDI) With Budesonide Hydrofluoroalkanes (HFA) pMDI, in Hispanic Subjects With ICS Dependent Asthma
NCT00419757 ·Status: COMPLETED ·Phase: PHASE3
-
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
NCT01136655 ·Status: COMPLETED ·Phase: PHASE2
-
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)
NCT00915538 ·Status: COMPLETED ·Phase: PHASE4
-
Symbicort in Asthmatic Children - SEEDLING
NCT00651547 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5
NCT00652002 ·Status: COMPLETED ·Phase: PHASE3
-
Pharmacokinetic Study on Budesonide/Formoterol Device-metered Dry Powder Inhalers
NCT01668121 ·Status: COMPLETED ·Phase: PHASE1
-
Gemini Symbicort pMDI
NCT00646516 ·Status: COMPLETED ·Phase: PHASE3
-
Real Life Effectiveness in Asthma of Symbicort Single Inhaler Therapy
NCT00319306 ·Status: COMPLETED ·Phase: PHASE3