Gemini Symbicort pMDI
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00646516
First received: March 26, 2008
Last updated: January 21, 2011
Last verified: January 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Mild or Moderate Asthma |
Drug: budesonide/formoterol (Symbicort) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Change from start of treatment in evening pre-dose FEV1 [ Time Frame: 2, 6 and 12 weeks after starting treatment ]
Secondary Outcome Measures:
- Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes [ Time Frame: Daily ]
- 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 ]
| Estimated Enrollment: | 615 |
| Study Start Date: | October 2003 |
| Study Completion Date: | February 2005 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: budesonide/formoterol (Symbicort)
Other Name: Symbicort
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00646516 History of Changes |
| Other Study ID Numbers: | D5896C00001 |
| Study First Received: | March 26, 2008 |
| Last Updated: | January 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Asthma inhaled corticosteroids Symbicort budesonide/formoterol budesonide |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Budesonide Formoterol Symbicort Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anti-Inflammatory Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013