Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT02062463
- Lead Sponsor
- 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, that is, better asthma control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 485
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The participant 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).
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The participant is receiving step 3 or 4 therapy for asthma as defined by the British Thoracic Society (BTS) guidelines (daily doses of beclomethasone dipropionate [BDP]-equivalent ICS) ≥800 mcg to 2000 μg as part of fixed- or free combinations with long-acting β2-agonists (LABA).
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If participant is a female of childbearing potential (post-menarche or less than 2 years post-menopausal or not surgically sterile), the participant 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.
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The participant, 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.
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The participant is SPIROMAX and TURBOHALER naïve (no use of a SYMBICORT TURBOHALER device in the last 6 months, minimizing carryover from prior device use).
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If female and of childbearing potential, the participant must have a negative urine pregnancy test.
- other criteria apply, please contact the investigator for additional information.
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The participant 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 participant.
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The participant has participated in a Teva-sponsored clinical study with BF SPIROMAX in the last 6 months.
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The participant is a pregnant, attempting to become pregnant, or breast feeding. (Any woman becoming pregnant during the study will be withdrawn from the study.)
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The participant has used a clinical trial investigational drug within 1 month before the screening visit.
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The participant 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 1.
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The participant is currently receiving any OCS (including long or short courses).
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The participant has a significant chronic lower respiratory tract disease other than asthma (for example 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.
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The participant has a known allergy or severe sensitivity to the constituents of the study drugs (SPIROMAX or TURBOHALER),for example, to lactose or to milk protein.
- other criteria apply, please contact the investigator for additional information.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 2: BF Spiromax Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX Participants who have currently received 800 to 1000 micrograms (μg) beclomethasone-equivalent inhaled corticosteroid (ICS) per day will receive budesonide/formoterol twice daily using the BF Spiromax 160/4.5 device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 640 μg and 18 μg, respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 1280 μg and 36 μg, respectively. Stage 2: Symbicort Turbohaler SYMBICORT TURBOHALER budesonide and formoterol fumarate Participants who have currently received 800 to 1000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 800 μg and 24 μg respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 1600 μg and 48 μg respectively.
- Primary Outcome Measures
Name Time Method Stage 1: Percentage of Participants Achieving Device Mastery Baseline (Day 1) Device mastery was defined as absence of healthcare professional (HCP)-observed errors by the end of Step 3 of a 6-step standardized device training protocol for empty Spiromax compared to empty Turbohaler. The 6 steps of device training protocol were: Step 1 - Intuitive use; Step 2 - Patient information leaflet; Step 3 - Instructional video; Step 4 - HCP tuition; Step 5 - HCP tuition (1st repeat); Step 6 - HCP tuition (2nd repeat).
Stage 2: Percentage of Participants Maintaining Device Mastery Baseline up to Week 12 Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use.
- Secondary Outcome Measures
Name Time Method Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer]) Baseline up to Week 12 Composite score calculated as the sum of nurse observed errors and technology-observed errors.
Stage 2: Total Number of Handling Errors Baseline up to Week 12 Total number of device handling errors included HCP observed errors and technology observed errors.
Stage 2: Change in Handling Errors From Stage 1 to Stage 2 Baseline (Day 1), Week 12 The difference in the number of handling errors identified after participant training using the patient device information leaflet at stage 1 and after 12 weeks of treatment (end of stage 2).
Stage 2: Number of Participants With Severe Asthma Exacerbations Week 12 Severe asthma exacerbation was defined as a hospitalization or emergency room attendance for asthma, or an acute course of oral corticosteroids (OCS).
Stage 1: Percentage of Participants Achieving Device Mastery by Step 1 Day 1 The number of participants achieving device mastery by Step 1 (no training/intuitive use) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors.
Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters) Baseline up to Week 12 Treatment adherence was categorized (as less than or equal to 50%, 51%-70%, 71%-99%, and 100%) and compared across treatment groups using a chi-square test.
Stage 2: Change From Baseline in 6-Item Asthma Control Questionnaire (ACQ) (Excluding Forced Expiratory Volume in 1 Second [FEV1] Question) Score at Weeks 4, 8, and 12 Baseline, Weeks 4, 8, and 12 The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted forced expiratory volume in 1 second (FEV1) on a 7-point scale (0 to 6). The score is the mean of the first 6 questions (excluding the FEV1 question), generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement.
Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score Baseline Up to Week 12 The impact of maintaining device mastery on asthma control was assessed by comparing the 7-item ACQ scores for participants with and without device mastery. The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device.
Stage 1: Percentage of Participants Achieving Device Mastery by Step 2 Day 1 The number of participants achieving device mastery by Step 2 (patient device information leaflet) of the device training process. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device. The 6 training steps were as follows: Step 1, intuitive use; Step 2, patient device information leaflet; Step 3, instructional video; Step 4, nurse tuition; Step 5, nurse tuition (1st repeat); Step 6, nurse tuition (2nd repeat). After each training step an assessment of device use was carried out by the nurse using a pre-defined list of inhaler errors.
Stage 1: Number of Nurse-Observed Errors Day 1 Stage 2: Time to First Treatment Failure Baseline up to Week 12 Time to treatment failure was defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection.
Stage 1: Number of Steps Taken to Achieve Device Mastery Baseline (Day 1) Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score Baseline (Day 1) The PASAPQ is a multi-item measure of inhalation device satisfaction and preference designed specifically for participants with asthma and chronic obstructive pulmonary disease. The PASAPQ includes a total of 14 device satisfaction items, including an overall satisfaction item. The total score was the sum of the 13 items related to performance and convenience domains (7 items for performance domain: Questions 1-5, 10-11, and 6 items for convenience domain: Questions 6-9, 12-13). Each PASAPQ item had response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total score, the items within each domain were first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction.
Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer) Week 12 Stage 2: Change From Baseline in 7-Item ACQ Baseline, Week 12 The ACQ is a 7-item, validated tool for assessing asthma control (Juniper et al 1999). Thinking about their asthma for the last 7 days, participants were asked to evaluate their asthma against 5 symptom items and a rescue bronchodilator use question using a 7-point scale (0=no impairment and 6=maximum impairment). Spirometry data were used to grade the percent predicted FEV1 on a 7-point scale (0 to 6). The ACQ score is the mean of the 7 questions, generating a value from 0 (totally controlled) to 6 (severely uncontrolled). A negative change from Baseline indicates improvement.
Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure Baseline Up to Week 12 The impact of maintaining device mastery on time to treatment failure (defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection) was assessed by comparing the time to treatment failure for participants with and without device mastery. Device mastery was defined as the absence of nurse-observed errors by the end of Step 3 of a 6-step standardized device training protocol for each device.
Number of Participants With Adverse Events (AEs) Baseline up to Week 12 An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Trial Locations
- Locations (74)
Teva Investigational Site 34111
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34105
🇬🇧Stanley, United Kingdom
Teva Investigational Site 34117
🇬🇧Stalham, United Kingdom
Teva Investigational Site 34115
🇬🇧Wisbech, United Kingdom
Teva Investigational Site 34103
🇬🇧Beccles, United Kingdom
Teva Investigational Site 34122
🇬🇧Chipping Norton, United Kingdom
Teva Investigational Site 34143
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34092
🇬🇧Axbridge, United Kingdom
Teva Investigational Site 34081
🇬🇧Babbacombe, United Kingdom
Teva Investigational Site 34144
🇬🇧Bishops Stortford, United Kingdom
Teva Investigational Site 34066
🇬🇧Burnhope, United Kingdom
Teva Investigational Site 34064
🇬🇧Bury St Edmunds, United Kingdom
Teva Investigational Site 34107
🇬🇧Bury St Edmunds, United Kingdom
Teva Investigational Site 34134
🇬🇧Clacton-on-Sea, United Kingdom
Teva Investigational Site 34063
🇬🇧Chippenham, United Kingdom
Teva Investigational Site 34135
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34120
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34126
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34083
🇬🇧East Hunsbury, United Kingdom
Teva Investigational Site 34145
🇬🇧East Tillbury, United Kingdom
Teva Investigational Site 34075
🇬🇧Daventry, United Kingdom
Teva Investigational Site 34112
🇬🇧Daventry, United Kingdom
Teva Investigational Site 34099
🇬🇧Exmouth, United Kingdom
Teva Investigational Site 34102
🇬🇧Goldhay, United Kingdom
Teva Investigational Site 34139
🇬🇧Hemel Henpstead, United Kingdom
Teva Investigational Site 34079
🇬🇧Harrogate, United Kingdom
Teva Investigational Site 34142
🇬🇧Hinckley, United Kingdom
Teva Investigational Site 34116
🇬🇧Huntingdon, United Kingdom
Teva Investigational Site 34113
🇬🇧Ipswich, United Kingdom
Teva Investigational Site 34098
🇬🇧Lancashire, United Kingdom
Teva Investigational Site 34141
🇬🇧Leigh-on-Sea, United Kingdom
Teva Investigational Site 34128
🇬🇧Leicester, United Kingdom
Teva Investigational Site 34127
🇬🇧Leicester, United Kingdom
Teva Investigational Site 34082
🇬🇧Liskeard, United Kingdom
Teva Investigational Site 34146
🇬🇧Lister House, United Kingdom
Teva Investigational Site 34147
🇬🇧Liverpool, United Kingdom
Teva Investigational Site 34080
🇬🇧Loughborough, United Kingdom
Teva Investigational Site 34138
🇬🇧Luton, United Kingdom
Teva Investigational Site 34086
🇬🇧Lowestoft, United Kingdom
Teva Investigational Site 34076
🇬🇧Manchester, United Kingdom
Teva Investigational Site 34106
🇬🇧Norwich', United Kingdom
Teva Investigational Site 34109
🇬🇧Newton Aycliffe, United Kingdom
Teva Investigational Site 34095
🇬🇧Norwich, United Kingdom
Teva Investigational Site 34108
🇬🇧Norwich, United Kingdom
Teva Investigational Site 34091
🇬🇧Norwich, United Kingdom
Teva Investigational Site 34085
🇬🇧Oadby, United Kingdom
Teva Investigational Site 34123
🇬🇧Norwich, United Kingdom
Teva Investigational Site 34070
🇬🇧Oldham, United Kingdom
Teva Investigational Site 34067
🇬🇧Strensall, United Kingdom
Teva Investigational Site 34114
🇬🇧Orby, United Kingdom
Teva Investigational Site 34124
🇬🇧Reading, United Kingdom
Teva Investigational Site 34100
🇬🇧Sheringham, United Kingdom
Teva Investigational Site 34118
🇬🇧Oxon, United Kingdom
Teva Investigational Site 34065
🇬🇧Stowmarket, United Kingdom
Teva Investigational Site 34078
🇬🇧Swindon, United Kingdom
Teva Investigational Site 34084
🇬🇧Wells-Next-Sea, United Kingdom
Teva Investigational Site 34069
🇬🇧Woodbridge, United Kingdom
Teva Investigational Site 34140
🇬🇧Thaxted, United Kingdom
Teva Investigational Site 34096
🇬🇧Thornton-Cleveleys, United Kingdom
Teva Investigational Site 34071
🇬🇧Waterlooville, United Kingdom
Teva Investigational Site 34073
🇬🇧Waterlooville, United Kingdom
Teva Investigational Site 34074
🇬🇧Woodbridge, United Kingdom
Teva Investigational Site 34101
🇬🇧York, United Kingdom
Teva Investigational Site 34110
🇬🇧Exmouth, United Kingdom
Teva Investigational Site 34072
🇬🇧Cheltenham, United Kingdom
Teva Investigational Site 34136
🇬🇧Colchester, United Kingdom
Teva Investigational Site 34119
🇬🇧Great Yarmouth, United Kingdom
Teva Investigational Site 34068
🇬🇧Harrogate, United Kingdom
Teva Investigational Site 34089
🇬🇧Redditch, United Kingdom
Teva Investigational Site 34137
🇬🇧Pickering, United Kingdom
Teva Investigational Site 34088
🇬🇧Trowbridge, United Kingdom
Teva Investigational Site 34077
🇬🇧Trowbridge, United Kingdom
Teva Investigational Site 34121
🇬🇧Wymondham, United Kingdom
Teva Investigational Site 34090
🇬🇧Worcester, United Kingdom