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Titratable Dosing in Moderate to Severe Asthmatics

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ClinicalTrials.gov Identifier: NCT00651768
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol Drug: Symbicort pMDI + budesonide HFA pMDI Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A 52 wk Randomized, Doubleblind, Single Dummy, Parallel Group Multicenter Phase 3 Study Comparing the Long Term Safety of Symbicort pMDI 4x160/4.5mcg Bid to SymbicortpMDI 2x160/4.5mcg Bid & Budesonide HFA pMDI 4x160mcg Bid in Adult and Adolescent Subjects With Asthma
Study Start Date : August 2003
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1 Drug: budesonide/formoterol
Other Name: Symbicort

Sham Comparator: 2 Drug: Symbicort pMDI + budesonide HFA pMDI
Symbicort 2 X 160/4.5mcg & budesonide HFA pMDI 4 X 160mcg




Primary Outcome Measures :
  1. Asthma exacerbations, ECG and Holter monitors, lung function, adverse events, requirement of other asthma therapies and other routine safety assessments. [ Time Frame: 7 assessments within 12 month treatment period ]

Secondary Outcome Measures :
  1. To measure changes in lung function tests, patient reported outcomes and usage of medical resource [ Time Frame: 7 assessments within 12 month treatment period ]
  2. Blood levels of budesonide and formoterol [ Time Frame: 10 blood samples taken at 1 visit in a sub-set of patients ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma and baseline lung function tests, symptoms and medication use 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 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
  • Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

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): NCT00651768


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca

ClinicalTrials.gov Identifier: NCT00651768     History of Changes
Other Study ID Numbers: SD-039-0728
D5896C00728
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
asthma
adults
adolescents
safety
Symbicort
budesonide/formoterol
budesonide

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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