Gemini Symbicort pMDI

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. Identifier: NCT00646516
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : January 24, 2011
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Brief Summary:
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.

Condition or disease Intervention/treatment Phase
Mild or Moderate Asthma Drug: budesonide/formoterol (Symbicort) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 615 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Rand, Doubleblind, Activecontrolled, Parallel-grp,Singledummy, Multicenter,12 wk Study to Assess the Effic.&Safety of Symbicort pMDI 2x160/4.5mcg QD Compared to Symb. pMDI 2x80/4.5mcg QD, Symb. pMDI 2x80/4.5mcg Bid and to Budesonide pMDI 2x160 Mcg QD in Asthmatic Sub's12yrs and Over
Study Start Date : October 2003
Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Change from start of treatment in evening pre-dose FEV1 [ Time Frame: 2, 6 and 12 weeks after starting treatment ]

Secondary Outcome Measures :
  1. Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes [ Time Frame: Daily ]
  2. Investigate safety profile of Symbicort and budesonide [ Time Frame: Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of asthma
  • Baseline lung function tests as determined by protocol.
  • Required and received treatment with inhaled corticosteroids and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.

Exclusion Criteria:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroid within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
  • Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

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 identifier (NCT number): NCT00646516

Sponsors and Collaborators
Study Director: Liza O'Dowd, MD AstraZeneca
Study Chair: Catherine Bonuccelli AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00646516     History of Changes
Other Study ID Numbers: D5896C00001
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
inhaled corticosteroids

Additional relevant MeSH terms:
Formoterol Fumarate
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
Hormones, Hormone Substitutes, and Hormone Antagonists