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Symbicort Onset of Action 1

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ClinicalTrials.gov Identifier: NCT00646620
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : April 6, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol (Symbicort) Drug: fluticasone/salmeterol (Advair Diskus) Drug: albuterol (Ventolin) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.
Study Start Date : April 2003
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
budesonide/formoterol
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
Active Comparator: 2
fluticasone/salmeterol
Drug: fluticasone/salmeterol (Advair Diskus)
Other Name: Advair Diskus
Active Comparator: 3
albuterol
Drug: albuterol (Ventolin)
Other Name: Ventolin



Primary Outcome Measures :
  1. FEV1 3 minutes post dose [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]

Secondary Outcome Measures :
  1. 12 hour serial FEV1 [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]
  2. Patients perception of effect [ Time Frame: 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma and baseline lung function test results as determined by protocol
  • Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol

Exclusion Criteria:

  • Severe asthma or asthma markedly affected by seasonal factors
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

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): NCT00646620


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca

ClinicalTrials.gov Identifier: NCT00646620     History of Changes
Other Study ID Numbers: SD-039-0732
D5896C00732
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: April 6, 2009
Last Verified: April 2009

Keywords provided by AstraZeneca:
asthma
bronchodilatation
Symbicort
budesonide/formoterol
Advair Diskus
Ventolin

Additional relevant MeSH terms:
Fluticasone
Budesonide
Formoterol Fumarate
Salmeterol Xinafoate
Albuterol
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Budesonide, Formoterol Fumarate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Sympathomimetics