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Symbicort Onset of Action 2

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ClinicalTrials.gov Identifier: NCT00646009
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : January 24, 2011
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 Drug: fluticasone/salmeterol Drug: albuterol Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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 : March 2003
Actual Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Active Comparator: 2
fluticasone/salmeterol
Drug: fluticasone/salmeterol
Other Name: Advair Diskus

Active Comparator: 3
albuterol
Drug: albuterol
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: Patients perception of effect ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosis of asthma and baseline lung function test results as determined by the protocol
  • Required and received inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

  • Severe asthma or asthma that is markedly effected by seasonal factors
  • Has required and received non-inhaled corticosteroids within the 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): NCT00646009


Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Catherine Bonuccelli AstraZeneca

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ClinicalTrials.gov Identifier: NCT00646009     History of Changes
Other Study ID Numbers: SD-039-0733
D5896C00733
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
asthma
adults
Symbicort
budesonide/formoterol
Advair Diskus
Ventolin
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Albuterol
Formoterol Fumarate
Salmeterol Xinafoate
Fluticasone-Salmeterol 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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists