Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 57 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 (SYGMA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02224157
Recruitment Status : Completed
First Posted : August 25, 2014
Last Update Posted : December 7, 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 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: budesonode bid + terbutaline 'as needed' Phase 3

Detailed Description:
A 52-week, double-blind, randomised, multi-centre, phase III, parallel-group 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 Pulmicort (budesonide) Turbuhaler 200 μg twice daily plus terbutaline Turbuhaler 0.4 mg 'as needed'

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4215 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 Pulmicort Twice Daily Plus Terbutaline 'as Needed' in Adult and Adolescent Patients With Asthma
Actual Study Start Date : November 28, 2014
Actual Primary Completion Date : August 16, 2017
Actual Study Completion Date : August 16, 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: Pulmicort bid + terbutaline 'as needed'
Pulmicort 200 μg Turbuhaler bid + terbutaline 0.4 mg Turbuhaler 'as needed'
Drug: budesonode 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. Annual severe asthma exacerbation rate [ Time Frame: up to 52 weeks ]

Secondary Outcome Measures :
  1. Time to first severe asthma exacerbation [ Time Frame: up to 52 weeks ]
  2. Average change from baseline in pre-dose FEV1 [ Time Frame: study weeks 0,17, 34, 52 ]
  3. Time to study specific asthma related discontinuation [ Time Frame: up to 52 weeks ]
    Study scpecific discontinuation of IP criteria: - A severe asthma exacerbation with a duration for more than 3 weeks - Three severe asthma exacerbations during 6 months

  4. Average change from baseline in 'as needed' use [ Time Frame: up to 52 weeks ]

    'As-needed'-use will be calculated as the cumulative doses of 'as-needed' medication divided by the follow-up time (number of days).

    For Symbicort treatment arm 'as needed' will be Symbicort, while for the Pulmicort treatment arm 'as needed' will be terbutaline.

    Change from baseline will be calculated for each patient, where baseline is defined as the 'as needed' use 10 days prior to randomisation during run-in.


  5. Change from baseline in percent of 'as needed' free days [ Time Frame: up to 52 weeks ]
  6. Percentage of controller use days [ Time Frame: up to 52 weeks ]
  7. Average change from baseline in Asthma Control Questionnaire (5-item version) - ACQ-5 score [ Time Frame: study weeks 0, 17, 34, 52 ]
  8. Average change from baseline in Asthma Quality of Life Questionnaire Standardised Version - AQLQ(S) score [ Time Frame: study weeks 0,17, 34, 52 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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 GINA step 2 treatment
  5. Patients treated with a short acting inhaled bronchodilator(s) only should have pre-bronchodilator FEV1 ≥ 60 % of predicted normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN
  6. Patients treated with low stable dose of ICS or leukotriene antagonists in addition to short acting inhaled 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 short acting inhaled bronchodilator(s) within 30 days prior to Visit 1 and from Visit 1 until randomization
  3. Patient has required treatment with oral, rectal or parenteral GCS within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1
  4. Current or previous smoker 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): NCT02224157


  Show 343 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Study Director: Carin Jorup, MD AstraZeneca Research & Development

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02224157     History of Changes
Other Study ID Numbers: D589SC00003
2013-004473-28 ( EudraCT Number )
First Posted: August 25, 2014    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Layout table for MeSH terms
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