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Trial record 83 of 183 for:    Foradil Combi OR symbicort OR (Budesonide AND formeterol)

A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma. (SYGMA1)

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ClinicalTrials.gov Identifier: NCT02149199
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this study is to test if Symbicort® (budesonide/formoterol) Turbuhaler® is effective in treating asthma when used 'as needed' in patients with milder asthma. The efficacy of Symbicort® 'as needed' will be compared with: 1) terbutaline Turbuhaler® 'as needed' and with 2) Pulmicort (budesonide) Turbuhaler® twice daily plus terbutaline Turbuhaler® 'as needed'.

Condition or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol 'as needed' + budesonide placebo bid Drug: terbutaline 'as needed' + placebo budesonide bid Drug: budesonide bid + terbutaline 'as needed' Phase 3

Detailed Description:
A 52-week, double-blind, randomised, multi-centre, parallel-group, Phase III study in patients 12 years and older with asthma, evaluating the efficacy and safety of Symbicort® (budesonide/formoterol) Turbuhaler® 160/4.5 μg 'as needed' compared with terbutaline Turbuhaler® 0.4 mg 'as needed' and with Pulmicort® (budesonide) Turbuhaler® 200 μg twice daily plus terbutaline Turbuhaler® 0.4 mg 'as needed'

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3850 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Comparing Symbicort® 'as Needed' With Terbutaline 'as Needed' and With Pulmicort® Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma.
Actual Study Start Date : July 7, 2014
Actual Primary Completion Date : August 2, 2017
Actual Study Completion Date : August 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Symbicort 'as needed'+placebo Pulmicort bid
Symbicort (budesonide/formoterol) Turbuhaler 160/4.5 μg 'as needed' + Placebo Pulmicort Turbuhaler 200 μg bid
Drug: budesonide/formoterol 'as needed' + budesonide placebo bid
Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Active Comparator: terbutaline 'as needed'+placebo Pulmicort bid
terbutaline Turbuhaler 0.4 mg 'as needed' + placebo Pulmicort 200 μg Turbuhaler bid
Drug: terbutaline 'as needed' + placebo budesonide bid
Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment

Active Comparator: Pulmicort bid + terbutaline 'as needed'
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Drug: budesonide bid + terbutaline 'as needed'
Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment




Primary Outcome Measures :
  1. 'Well-controlled asthma week' - a derived binary variable (Yes/No) [ Time Frame: weekly, up to 52 weeks ]

    A well-controlled asthma week is defined as the fulfilment of both conditions A) and B) below: A) Two or more of the following criteria are fulfilled: − No more than 2 days with a daily asthma symptom score >1 − No more than 2 days of 'as needed' medication use, up to a maximum of 4 occasions per week (multiple occasions per day should be regarded as separate occasions) − Morning PEF ≥80% of Predicted Normal every day B) Both of the following criteria are fulfilled: − No nighttime awakenings due to asthma − No additional inhaled and/or systemic glucocorticosteroid treatment due to asthma.

    For each patient and study week, the binary variable well-controlled asthma week will be derived. In addition, for each week the percent of patients with well-controlled asthma week will also be derived.

    It is required that the eDiary has to be completed on at least 5 days in a week to be a well-controlled asthma week.



Secondary Outcome Measures :
  1. Time to first severe asthma exacerbation [ Time Frame: up to 52 weeks ]
  2. Time to first moderate or severe asthma exacerbation [ Time Frame: up to 52 weeks ]
  3. Average change from baseline in pre-dose FEV1 [ Time Frame: Study weeks 0,4,16,28,40,52 ]
  4. Average change from baseline in Morning PEF [ Time Frame: up to 52 weeks ]
  5. Average change from baseline in Evening PEF [ Time Frame: up to 52 weeks ]
  6. Average change from baseline in number of inhalations of 'as needed' medication [ Time Frame: up to 52 weeks ]
  7. Average change from baseline in symptom score [ Time Frame: up to 52 weeks ]
  8. Percentage of Nighttime awakenings due to asthma [ Time Frame: up to 52 weeks ]
  9. Percentage of Symptom-free days [ Time Frame: up to 52 weeks ]
  10. Percentage of 'As needed' free days [ Time Frame: up to 52 weeks ]
  11. Percentage of Asthma control days [ Time Frame: up to 52 weeks ]
  12. Time to asthma related discontinuation [ Time Frame: up to 52 weeks ]
  13. Poorly controlled asthma weeks [ Time Frame: Weekly for up to 52 weeks ]
  14. Time to additional steroids for asthma [ Time Frame: up to 52 weeks ]
  15. Average change from baseline in Asthma Control Questionnaire (ACQ-5) [ Time Frame: Study weeks 0,4,16,28,40,52 ]
  16. Average change from baseline in Asthma Quality of Life Questionnaire; standard version (AQLQ(S)) [ Time Frame: Study weeks 0,16,28,40,52 ]
  17. Percentage of controller use days [ Time Frame: up to 52 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 130 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
INCLUSION CRITERIA 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler 'as needed' on at least 3 separate days during the last week of the run in period. EXCLUSION CRITERIA 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. Patient has had an asthma worsening requiring change in treatment other than inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.

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): NCT02149199


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Sponsors and Collaborators
AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02149199     History of Changes
Other Study ID Numbers: D589SC00001
2013-004474-96 ( EudraCT Number )
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
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Formoterol Fumarate
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
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
Sympathomimetics