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

Phase 3CompletedNCT02062463

Teva Branded Pharmaceutical Products R&D, Inc.485 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

485

Conditions

Asthma

Interventions

Budesonide and formoterol fumarate dehydrate (BF) SPIROMAXDRUG

SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg)

SYMBICORT TURBOHALER budesonide and formoterol fumarateDRUG

SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (74)

Outcomes

Primary Outcomes

Stage 1: Percentage of Participants Achieving Device Mastery

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).

Time frame: Baseline (Day 1)

Stage 2: Percentage of Participants Maintaining Device Mastery

Maintenance of device mastery was defined as absence of HCP-observed errors after 12 weeks of device use.

Time frame: Baseline up to Week 12

Secondary Outcomes

Stage 1: Percentage of Participants Achieving Device Mastery by Step 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.

Time frame: Day 1

Stage 1: Percentage of Participants Achieving Device Mastery by Step 2

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.

Data from ClinicalTrials.gov

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Teva Investigational Site 34092

Axbridge, United Kingdom

Teva Investigational Site 34081

Babbacombe, United Kingdom

Teva Investigational Site 34103

Beccles, United Kingdom

Teva Investigational Site 34144

Bishop's 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 34072

Cheltenham, United Kingdom

Teva Investigational Site 34063

Chippenham, United Kingdom

Teva Investigational Site 34122

Chipping Norton, United Kingdom

...and 64 more locations

Stage 1: Number of Steps Taken to Achieve Device Mastery

Time frame: Baseline (Day 1)

Stage 1: Number of Nurse-Observed Errors

Time frame: 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 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.

Time frame: Baseline (Day 1)

Composite Endpoint: Stage 2: Total Number of Observed Errors (Nurse and Technology [Vitalograph Pneumotrac Spirometer])

Composite score calculated as the sum of nurse observed errors and technology-observed errors.

Time frame: Baseline up to Week 12

Stage 2: Number of Technology-Observed Errors (Vitalograph Pneumotrac Spirometer)

Time frame: Week 12

Stage 2: Total Number of Handling Errors

Total number of device handling errors included HCP observed errors and technology observed errors.

Time frame: Baseline up to Week 12

Stage 2: Change in Handling Errors From Stage 1 to Stage 2

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).

Time frame: Baseline (Day 1), Week 12

Stage 2: Number of Participants In Pre-specified Treatment Adherence Categories (Assessed by Device Dose Counters)

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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: Baseline, Week 12

Stage 2: Time to First Treatment Failure

Time to treatment failure was defined as change of asthma treatment or treatment for an asthma exacerbation or lower respiratory tract infection.

Time frame: Baseline up to Week 12

Stage 2: Number of Participants With Severe Asthma Exacerbations

Severe asthma exacerbation was defined as a hospitalization or emergency room attendance for asthma, or an acute course of oral corticosteroids (OCS).

Time frame: Week 12

Stage 2: Impact of Maintaining Device Mastery on Time to Treatment Failure

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.

Time frame: 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 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.

Time frame: Baseline Up to Week 12

Number of Participants With Adverse Events (AEs)

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'.

Time frame: Baseline up to Week 12