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

Study Overview
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Brief Summary
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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.

Official Title
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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 With SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg) as Treatment for Adult Patients With Asthma (The Easy Low Instruction Over Time [ELIOT] Study)

Conditions
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Asthma

Intervention / Treatment
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* Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX
* Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). 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). 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. 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. 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). 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. Exclusion Criteria: 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. The participant has participated in a Teva-sponsored clinical study with BF SPIROMAX in the last 6 months. 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.) The participant has used a clinical trial investigational drug within 1 month before the screening visit. 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. The participant is currently receiving any OCS (including long or short courses). 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Stage 1: Empty Spiromax Followed by Empty Turbohaler<br>Participants will be trained on the proper use of empty Spiromax followed by empty Turbohaler devices. | |
| No Intervention: Stage 1: Empty Turbohaler Followed by Empty Spiromax<br>Participants will be trained on the proper use of empty Turbohaler followed by empty Spiromax devices. | |
| Experimental: Stage 2: BF Spiromax<br>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. | Drug: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX<br>* SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg)<br>* Other names: SPIROMAX®;|
| Active Comparator: Stage 2: Symbicort Turbohaler<br>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. | Drug: SYMBICORT TURBOHALER budesonide and formoterol fumarate<br>* SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)<br>* Other names: TURBOHALER®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 1: Percentage of Participants Achieving Device Mastery |  | Day 1 | 
| Stage 2: Percentage of Participants Maintaining Device Mastery |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 1: Percentage of Participants Achieving Device Mastery by Step 1 |  | Day 1 | 
| Stage 1: Percentage of Participants Achieving Device Mastery by Step 2 |  | Day 1 | 
| Stage 1: Number of Steps Taken to Achieve Device Mastery |  | Day 1 | 
| Stage 1: Number of Nurse-Observed Errors |  | Day 1 | 
| Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score | 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 will be 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 will have response options ranging from 1 (very dissatisfied) to 7 (very satisfied). To calculate the total score, the items within each domain will be first summed and then transformed to a 0 (least) or 100 (most) point scale, with higher scores indicating greater satisfaction. | Day 1 | 
| Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer]) |  | Baseline up to Week 12 | 
| Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer) |  | Week 12 | 
| Stage 2: Total Number of Handling Errors |  | Baseline up to Week 12 | 
| Stage 2: Change in Handling Errors from Stage 1 to Stage 2 |  | Day 1, Week 12 | 
| Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters) |  | Baseline up to Week 12 | 
| 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 | 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 are 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 is 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 higher score indicates poorer asthma control. | Baseline, Weeks 4, 8, and 12 | 
| Stage 2: Change From Baseline in 7-Item ACQ | 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 are 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 is 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 higher score indicates poorer asthma control. | Baseline, Week 12 | 
| Stage 2: Time to First Treatment Failure |  | Baseline up to Week 12 | 
| Stage 2: Number of Participants With Severe Asthma Exacerbations |  | Week 12 | 
| Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure |  | Baseline Up to Week 12 | 
| Stage 2: Impact of Maintaining Device Mastery on Asthma Control Questionnaire Score | The impact of maintaining device mastery on asthma control will be 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 will be 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 will be 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 is 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. | Baseline Up to Week 12 | 
| Number of Participants With Adverse Events (AEs) |  | Baseline up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma