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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 Participants With Asthma

NCT ID: NCT02062463

Last Updated: 2024-03-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-28

Study Completion Date

2015-03-13

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stage 1: Empty Spiromax Followed by Empty Turbohaler

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Stage 1: Empty Turbohaler Followed by Empty Spiromax

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Stage 2: 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.

Group Type EXPERIMENTAL

Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX

Intervention Type DRUG

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

Stage 2: Symbicort Turbohaler

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.

Group Type ACTIVE_COMPARATOR

SYMBICORT TURBOHALER budesonide and formoterol fumarate

Intervention Type DRUG

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

Interventions

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Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX

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

Intervention Type DRUG

SYMBICORT TURBOHALER budesonide and formoterol fumarate

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

Intervention Type DRUG

Other Intervention Names

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SPIROMAX® SYMBICORT® TURBOHALER®

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 34092

Axbridge, , United Kingdom

Site Status

Teva Investigational Site 34081

Babbacombe, , United Kingdom

Site Status

Teva Investigational Site 34103

Beccles, , United Kingdom

Site Status

Teva Investigational Site 34144

Bishop's Stortford, , United Kingdom

Site Status

Teva Investigational Site 34066

Burnhope, , United Kingdom

Site Status

Teva Investigational Site 34064

Bury St Edmunds, , United Kingdom

Site Status

Teva Investigational Site 34107

Bury St Edmunds, , United Kingdom

Site Status

Teva Investigational Site 34072

Cheltenham, , United Kingdom

Site Status

Teva Investigational Site 34063

Chippenham, , United Kingdom

Site Status

Teva Investigational Site 34122

Chipping Norton, , United Kingdom

Site Status

Teva Investigational Site 34134

Clacton-on-Sea, , United Kingdom

Site Status

Teva Investigational Site 34136

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34143

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34111

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34126

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34135

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34120

Colchester, , United Kingdom

Site Status

Teva Investigational Site 34075

Daventry, , United Kingdom

Site Status

Teva Investigational Site 34112

Daventry, , United Kingdom

Site Status

Teva Investigational Site 34083

East Hunsbury, , United Kingdom

Site Status

Teva Investigational Site 34145

East Tillbury, , United Kingdom

Site Status

Teva Investigational Site 34099

Exmouth, , United Kingdom

Site Status

Teva Investigational Site 34110

Exmouth, , United Kingdom

Site Status

Teva Investigational Site 34102

Goldhay, , United Kingdom

Site Status

Teva Investigational Site 34119

Great Yarmouth, , United Kingdom

Site Status

Teva Investigational Site 34079

Harrogate, , United Kingdom

Site Status

Teva Investigational Site 34068

Harrogate, , United Kingdom

Site Status

Teva Investigational Site 34139

Hemel Henpstead, , United Kingdom

Site Status

Teva Investigational Site 34142

Hinckley, , United Kingdom

Site Status

Teva Investigational Site 34116

Huntingdon, , United Kingdom

Site Status

Teva Investigational Site 34113

Ipswich, , United Kingdom

Site Status

Teva Investigational Site 34098

Lancashire, , United Kingdom

Site Status

Teva Investigational Site 34128

Leicester, , United Kingdom

Site Status

Teva Investigational Site 34127

Leicester, , United Kingdom

Site Status

Teva Investigational Site 34141

Leigh-on-Sea, , United Kingdom

Site Status

Teva Investigational Site 34082

Liskeard, , United Kingdom

Site Status

Teva Investigational Site 34146

Lister House, , United Kingdom

Site Status

Teva Investigational Site 34147

Liverpool, , United Kingdom

Site Status

Teva Investigational Site 34080

Loughborough, , United Kingdom

Site Status

Teva Investigational Site 34086

Lowestoft, , United Kingdom

Site Status

Teva Investigational Site 34138

Luton, , United Kingdom

Site Status

Teva Investigational Site 34076

Manchester, , United Kingdom

Site Status

Teva Investigational Site 34109

Newton Aycliffe, , United Kingdom

Site Status

Teva Investigational Site 34095

Norwich, , United Kingdom

Site Status

Teva Investigational Site 34108

Norwich, , United Kingdom

Site Status

Teva Investigational Site 34106

Norwich, , United Kingdom

Site Status

Teva Investigational Site 34091

Norwich, , United Kingdom

Site Status

Teva Investigational Site 34123

Norwich, , United Kingdom

Site Status

Teva Investigational Site 34085

Oadby, , United Kingdom

Site Status

Teva Investigational Site 34070

Oldham, , United Kingdom

Site Status

Teva Investigational Site 34114

Orby, , United Kingdom

Site Status

Teva Investigational Site 34118

Oxon, , United Kingdom

Site Status

Teva Investigational Site 34137

Pickering, , United Kingdom

Site Status

Teva Investigational Site 34124

Reading, , United Kingdom

Site Status

Teva Investigational Site 34089

Redditch, , United Kingdom

Site Status

Teva Investigational Site 34100

Sheringham, , United Kingdom

Site Status

Teva Investigational Site 34117

Stalham, , United Kingdom

Site Status

Teva Investigational Site 34105

Stanley, , United Kingdom

Site Status

Teva Investigational Site 34065

Stowmarket, , United Kingdom

Site Status

Teva Investigational Site 34067

Strensall, , United Kingdom

Site Status

Teva Investigational Site 34078

Swindon, , United Kingdom

Site Status

Teva Investigational Site 34140

Thaxted, , United Kingdom

Site Status

Teva Investigational Site 34096

Thornton-Cleveleys, , United Kingdom

Site Status

Teva Investigational Site 34088

Trowbridge, , United Kingdom

Site Status

Teva Investigational Site 34077

Trowbridge, , United Kingdom

Site Status

Teva Investigational Site 34071

Waterlooville, , United Kingdom

Site Status

Teva Investigational Site 34073

Waterlooville, , United Kingdom

Site Status

Teva Investigational Site 34084

Wells-Next-Sea, , United Kingdom

Site Status

Teva Investigational Site 34115

Wisbech, , United Kingdom

Site Status

Teva Investigational Site 34069

Woodbridge, , United Kingdom

Site Status

Teva Investigational Site 34074

Woodbridge, , United Kingdom

Site Status

Teva Investigational Site 34090

Worcester, , United Kingdom

Site Status

Teva Investigational Site 34121

Wymondham, , United Kingdom

Site Status

Teva Investigational Site 34101

York, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2013-004630-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BFS-AS-40035

Identifier Type: -

Identifier Source: org_study_id

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