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Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Patients With Asthma (ELIOT)

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ClinicalTrials.gov Identifier: NCT02062463
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief Summary:
This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, ie, better asthma control.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 12 Week, Randomized, Open-Label, Parallel Group Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® (160/4.5 and 320/9 mcg) as Compared to SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma
Study Start Date : June 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: SPIROMAX

Period 1 of this study will comprise a single visit wherein mastery of inhaler technique will be assessed. Empty training devices will be utilized for this period. Period 2 dosage will be equivalent to that received via the participants current device at baseline.

Participants receiving 800 mcg to 1000 mcg budesonide diphosphate (BDP)-equivalent inhaled corticosteroids at study entry will receive budesonide and formoterol at daily doses of 640 mcg and 18 mcg, respectively.

Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX
SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 mcg)
Other Name: SPIROMAX®

Active Comparator: TURBOHALER

Period 1 of this study will comprise a single visit wherein mastery of inhaler technique will be assessed. Empty training devices will be utilized for this period. Period 2 dosage will be equivalent to that received via the participants current device at baseline.

Participants receiving 1600 mcg to 2000 mcg budesonide diphosphate (BDP)-equivalent inhaled corticosteroids at study entry will receive budesonide and formoterol at daily doses of 1280 mcg and 36 mcg, respectively.

Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate
SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg)
Other Names:
  • SYMBICORT®
  • TURBOHALER®




Primary Outcome Measures :
  1. Total observed critical errors (technology and handling) [ Time Frame: 12 Weeks ]
  2. Treatment Adherence according to 6 step standardized device training [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Observed number of steps taken to achieve device mastery [ Time Frame: 12 Weeks ]
  2. Patient Satisfaction and Preference Questionnaire (PASAPQ) score [ Time Frame: 4 Months ]
    Fourteen questions which may be scored with answers that range from Very Dissatisfied to Very Satisfied

  3. Number of different handling errors identified following training [ Time Frame: 12 Weeks ]
  4. Change from baseline in the 6-item ASTHMA CONTROL QUESTIONNAIRE (ACQ) [ Time Frame: Baseline, week 4, 8, and 12 ]
    7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled)

  5. Number of participants with change in Asthma Treatment [ Time Frame: 4 Months ]
  6. Number of severe asthma exacerbations [ Time Frame: 4 Months ]
  7. Summary of Participants with Adverse Events [ Time Frame: 4 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent signed and dated by the adult patient before conducting any study related procedures.
  • The patient is a man or woman 18 through 75 years of age as of the screening visit.
  • The patient has a diagnosis of asthma in accordance with Global Initiative for Asthma (GINA) criteria as evidenced by a United Kingdom (UK) quality outcome framework approved Read code (UK diagnostic coding system).
  • The patient is receiving step 3 or 4 therapy for asthma as defined by the British Thoracic Society (BTS) guidelines (daily doses of BDP-equivalent inhaled corticosteroid (ICS) ≥800 mcg to 2000 mcg as part of fixed or free combinations with long-acting beta-agonists (LABA).
  • If patient is a female of childbearing potential (postmenarche or less than 2 years post-menopausal or not surgically sterile) the patient must be willing to commit to using a medically accepted method of contraception for the duration of study and 30 days after discontinuing study drug.
  • The patient, as judged by the investigator, must be willing and able to understand risks and benefits of study participation to give informed consent and to comply with all study requirements as specified in this protocol for the entire duration of their study participation.
  • The patient is SPIROMAX and TURBOHALER naïve (no use of a TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
  • If female, the patient must have a negative urine pregnancy test. o other criteria apply, please contact the investigator for additional information

Exclusion Criteria:

  • The patient has any clinically significant uncontrolled medical condition (treated or untreated) that, in the judgment of the investigator, will cause participation in the study to be detrimental to the patient.
  • The patient has participated in a Teva sponsored clinical study with BF SPIROMAX in the last 6 months.
  • The patient is a pregnant, attempting to become pregnant, or breast feeding. (Any woman becoming pregnant during the study will be withdrawn from the study.)
  • The patient has used a clinical trial investigational drug within 1 month before the screening visit.
  • The patient has an ongoing asthma exacerbation or has received OCS and/or antibiotics for a lower respiratory condition (proxy measure for identifying an asthma exacerbation and/or lower respiratory infection, suggestive of altered inspiratory capabilities) in the 2 weeks preceding visit
  • The patient is currently receiving any OCS (including long or short courses).
  • The patient has a significant chronic lower respiratory tract disease other than asthma eg chronic obstructive pulmonary disease (COPD), cystic fibrosis or interstitial lung disease. Conditions that are not predominant, such as minor degrees of bronchiectasis, are not a reason for exclusion.
  • The patient has a known allergy or severe sensitivity to the constituents of the study drugs (SPIROMAX or TURBOHALER) eg, to lactose or to milk protein.

    • other criteria apply, please contact the investigator for additional information

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): NCT02062463


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Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
Investigators
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Study Director: Sponsor's Medical Expert, MD Teva Pharmaceuticals USA

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT02062463     History of Changes
Other Study ID Numbers: BFS-AS-40035
2013-004630-14 ( EudraCT Number )
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: December 21, 2015
Last Verified: December 2015

Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Asthma

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