Symbicort Onset of Action 2

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00646009
First received: March 26, 2008
Last updated: January 21, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Asthma
Drug: budesonide/formoterol
Drug: fluticasone/salmeterol
Drug: albuterol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 48
Study Start Date: March 2003
Study Completion Date: August 2003
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT00646009

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Catherine Bonuccelli AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00646009     History of Changes
Other Study ID Numbers: SD-039-0733, D5896C00733
Study First Received: March 26, 2008
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Budesonide
Formoterol
Salmeterol
Fluticasone
Symbicort
Fluticasone, salmeterol drug combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on September 11, 2014