We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Symbicort in Asthmatic Children - SEEDLING

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: NCT00651547
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : March 30, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol Drug: budesonide Drug: formoterol Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5
Study Start Date : July 2002
Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: budesonide/formoterol
Other Name: Symbicort
Active Comparator: 2 Drug: budesonide
Active Comparator: 3 Drug: formoterol


Outcome Measures

Primary Outcome Measures :
  1. Morning PEF [ Time Frame: Daily ]

Secondary Outcome Measures :
  1. Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baseline lung function tests results as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

  • Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
  • Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651547


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca
More Information

ClinicalTrials.gov Identifier: NCT00651547     History of Changes
Other Study ID Numbers: SD-039-0718
D5896C00718
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: March 30, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Asthma
Symbicort
budesonide/formoterol
budesonide
formoterol
children

Additional relevant MeSH terms:
Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists