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Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

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ClinicalTrials.gov Identifier: NCT00658255
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

Condition or disease Intervention/treatment Phase
Stable Asthma Drug: budesonide/formoterol Drug: formoterol Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
Study Start Date : October 2002
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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

Active Comparator: 2 Drug: formoterol
Other Name: Oxis Turbuhaler




Primary Outcome Measures :
  1. Average FEV1 during 12 hours [ Time Frame: Once a week for 5 weeks during treatment period ]

Secondary Outcome Measures :
  1. Urine levels of formoterol in 2 different formulations [ Time Frame: Once a week (12 hour urine collection) for 5 weeks during treatment period ]
  2. Safety profiles of formoterol in 2 different formulations [ Time Frame: Once a week for 5 weeks during treatment period ]


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

Exclusion Criteria:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in 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): NCT00658255


Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Michael E Ruff, MD Pharmaceutical Research & Consulting Inc
Study Chair: Catherine Bonuccelli AstraZeneca

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ClinicalTrials.gov Identifier: NCT00658255     History of Changes
Other Study ID Numbers: SD-039-0729
D5896C00729
First Posted: April 14, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
stable asthma
adults
formoterol
Symbicort
Oxis Turbuhaler
bronchodilation

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
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