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A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00449501
First received: March 16, 2007
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.


Condition Intervention Phase
Asthma
Drug: Budesonide/formoterol pMDI
Drug: Budesonide HFA pMDI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Two-week, Randomised, Double-blind Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects (≥ 18 Years) With Mild to Moderate Asthma, Receiving SYMBICORT® pMDI 80/4.5 μg x 2 Actuations Twice Daily or Budesonide HFA pMDI 80 μg x 2 Act. Twice Daily

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group

Secondary Outcome Measures:
  • To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away

Enrollment: 134
Study Start Date: March 2007
Study Completion Date: November 2007
Intervention Details:
    Drug: Budesonide/formoterol pMDI
    Other Name: Symbicort
    Drug: Budesonide HFA pMDI
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female, > 18 years of age
  • Mild to moderate asthma requiring treatment with an inhaled corticosteroid
  • Diagnosis of asthma for at least 6 months

Exclusion Criteria:

  • Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
  • Subjects with severe asthma, as judged by investigator
  • Any significant disease or disorder that may jeopardize a subject's safety
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449501

  Show 46 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tomas LG Andersson, MD AstraZenenca
  More Information

Additional Information:
No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00449501     History of Changes
Other Study ID Numbers: D5896C00025
Study First Received: March 16, 2007
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Mild Asthma
Moderate Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Budesonide
Symbicort
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014