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

NCT02062463 | Completed Phase 3 Results

• 2 other identifiers: BFS-AS-400352013-004630-14
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 74

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  Baseline up to Week 12

Secondary Outcomes (17)

• 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

  Baseline (Day 1)

• Stage 1: Number of Nurse-Observed Errors

  Day 1

• Stage 1: Patient Satisfaction and Preference Questionnaire (PASAPQ) Total Score

  Baseline (Day 1)

Study Arms (4)

Stage 1: Empty Spiromax Followed by Empty Turbohaler

NO INTERVENTION

Participants will be trained on the proper use of empty Spiromax followed by empty Turbohaler devices.

Stage 1: Empty Turbohaler Followed by Empty Spiromax

NO INTERVENTION

Participants will be trained on the proper use of empty Turbohaler followed by empty Spiromax devices.

Stage 2: BF Spiromax

EXPERIMENTAL

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

Stage 2: Symbicort Turbohaler

ACTIVE COMPARATOR

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

Interventions

Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX DRUG

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

Also known as: SPIROMAX®

Stage 2: BF Spiromax

SYMBICORT TURBOHALER budesonide and formoterol fumarate DRUG

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

Also known as: SYMBICORT®, TURBOHALER®

Stage 2: Symbicort Turbohaler

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (74)

Teva Investigational Site 34092

Axbridge, BS26 2BJ, United Kingdom

Location

Teva Investigational Site 34081

Babbacombe, TQ1 3SL, United Kingdom

Location

Teva Investigational Site 34103

Beccles, NR34 9NX, United Kingdom

Location

Teva Investigational Site 34144

Bishop's Stortford, CM22 7EH, United Kingdom

Location

Teva Investigational Site 34066

Burnhope, DH7 0BD, United Kingdom

Location

Teva Investigational Site 34064

Bury St Edmunds, IP30 9QU, United Kingdom

Location

Teva Investigational Site 34107

Bury St Edmunds, IP32 7EW, United Kingdom

Location

Teva Investigational Site 34072

Cheltenham, GL50 4DP, United Kingdom

Location

Teva Investigational Site 34063

Chippenham, SN14 6GT, United Kingdom

Location

Teva Investigational Site 34122

Chipping Norton, OX7 6BW, United Kingdom

Location

Teva Investigational Site 34134

Clacton-on-Sea, CO15 4DA, United Kingdom

Location

Teva Investigational Site 34136

Colchester, CO1 2DL, United Kingdom

Location

Teva Investigational Site 34143

Colchester, CO1 2QS, United Kingdom

Location

Teva Investigational Site 34111

Colchester, CO2 7GH, United Kingdom

Location

Teva Investigational Site 34126

Colchester, CO3 4RA, United Kingdom

Location

Teva Investigational Site 34135

Colchester, CO3 4RY, United Kingdom

Location

Teva Investigational Site 34120

Colchester, CO7 9PP, United Kingdom

Location

Teva Investigational Site 34075

Daventry, NN11 4DY, United Kingdom

Location

Teva Investigational Site 34112

Daventry, NN11 5RA, United Kingdom

Location

Teva Investigational Site 34083

East Hunsbury, NN4 0NY, United Kingdom

Location

Teva Investigational Site 34145

East Tillbury, RM18 8SD, United Kingdom

Location

Teva Investigational Site 34099

Exmouth, EX8 2JF, United Kingdom

Location

Teva Investigational Site 34110

Exmouth, EX8 2JF, United Kingdom

Location

Teva Investigational Site 34102

Goldhay, PE2 5GP, United Kingdom

Location

Teva Investigational Site 34119

Great Yarmouth, NR31 0DW, United Kingdom

Location

Teva Investigational Site 34079

Harrogate, HG1 5AR, United Kingdom

Location

Teva Investigational Site 34068

Harrogate, HG1 5JP, United Kingdom

Location

Teva Investigational Site 34139

Hemel Henpstead, HP1 2LD, United Kingdom

Location

Teva Investigational Site 34142

Hinckley, LE10 1DS, United Kingdom

Location

Teva Investigational Site 34116

Huntingdon, PE28 4EQ, United Kingdom

Location

Teva Investigational Site 34113

Ipswich, IP1 6DW, United Kingdom

Location

Teva Investigational Site 34098

Lancashire, FY4 3AD, United Kingdom

Location

Teva Investigational Site 34128

Leicester, LE2 6UL, United Kingdom

Location

Teva Investigational Site 34127

Leicester, LE5 4BP, United Kingdom

Location

Teva Investigational Site 34141

Leigh-on-Sea, SS9 2SQ, United Kingdom

Location

Teva Investigational Site 34082

Liskeard, PL14 3XA, United Kingdom

Location

Teva Investigational Site 34146

Lister House, CM18 7LU, United Kingdom

Location

Teva Investigational Site 34147

Liverpool, L36 0UB, United Kingdom

Location

Teva Investigational Site 34080

Loughborough, LE11 1NH, United Kingdom

Location

Teva Investigational Site 34086

Lowestoft, NR33 8LG, United Kingdom

Location

Teva Investigational Site 34138

Luton, PU2 9SB, United Kingdom

Location

Teva Investigational Site 34076

Manchester, OL9 0LH, United Kingdom

Location

Teva Investigational Site 34109

Newton Aycliffe, DL5 4SE, United Kingdom

Location

Teva Investigational Site 34095

Norwich, NR11 6AA, United Kingdom

Location

Teva Investigational Site 34108

Norwich, NR12 8DU, United Kingdom

Location

Teva Investigational Site 34106

Norwich, NR3 2HW, United Kingdom

Location

Teva Investigational Site 34091

Norwich, NR5 0GB, United Kingdom

Location

Teva Investigational Site 34123

Norwich, NR5 9HA, United Kingdom

Location

Teva Investigational Site 34085

Oadby, LE2 4PE, United Kingdom

Location

Teva Investigational Site 34070

Oldham, OL9 8NH, United Kingdom

Location

Teva Investigational Site 34114

Orby, NN17 1QP, United Kingdom

Location

Teva Investigational Site 34118

Oxon, OX33 1YJ, United Kingdom

Location

Teva Investigational Site 34137

Pickering, YO18 8BL, United Kingdom

Location

Teva Investigational Site 34124

Reading, RG8 7DP, United Kingdom

Location

Teva Investigational Site 34089

Redditch, B98 0NR, United Kingdom

Location

Teva Investigational Site 34100

Sheringham, NR26 8RT, United Kingdom

Location

Teva Investigational Site 34117

Stalham, NR12 9BU, United Kingdom

Location

Teva Investigational Site 34105

Stanley, DH9 7TD, United Kingdom

Location

Teva Investigational Site 34065

Stowmarket, IP14 1NL, United Kingdom

Location

Teva Investigational Site 34067

Strensall, YO32 5UA, United Kingdom

Location

Teva Investigational Site 34078

Swindon, SN2 1UU, United Kingdom

Location

Teva Investigational Site 34140

Thaxted, CM6 2QN, United Kingdom

Location

Teva Investigational Site 34096

Thornton-Cleveleys, FY5 2TZ, United Kingdom

Location

Teva Investigational Site 34088

Trowbridge, BA14 8QA, United Kingdom

Location

Teva Investigational Site 34077

Trowbridge, BA14 9AR, United Kingdom

Location

Teva Investigational Site 34071

Waterlooville, PO7 5XP, United Kingdom

Location

Teva Investigational Site 34073

Waterlooville, PO7 7AH, United Kingdom

Location

Teva Investigational Site 34084

Wells-Next-Sea, NR23 1JP, United Kingdom

Location

Teva Investigational Site 34115

Wisbech, PE14 7RR, United Kingdom

Location

Teva Investigational Site 34069

Woodbridge, IP12 3DA, United Kingdom

Location

Teva Investigational Site 34074

Woodbridge, IP12 4FD, United Kingdom

Location

Teva Investigational Site 34090

Worcester, WR1 2BS, United Kingdom

Location

Teva Investigational Site 34121

Wymondham, NR18 0RF, United Kingdom

Location

Teva Investigational Site 34101

York, YO24 4HD, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D, Inc.

USMedInfo@tevapharm.com

1-888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 13, 2014
• Study Start: May 28, 2014
• Primary Completion: March 13, 2015
• Study Completion: March 13, 2015
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Locations

GB (74)