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Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®

NCT ID: NCT01803555

Last Updated: 2023-12-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

605 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-04

Study Completion Date

2014-03-20

Brief Summary

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The primary objective of the study is to establish whether budesonide/formoterol fumarate dihydrate (BF) Spiromax 160/4.5 micrograms (mcg) is as effective as Symbicort Turbohaler 200/6 mcg administered twice daily in participants with persistent asthma.

Detailed Description

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Conditions

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Asthma

Keywords

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Budesonide/Formoterol SPIROMAX® SYMBICORT® TURBOHALER® Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BF Spiromax

2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period.

Group Type EXPERIMENTAL

Budesonide/Formoterol SPIROMAX®

Intervention Type DRUG

BF Spiromax will be administered per dose and schedule specified in the arm.

SYMBICORT placebo

Intervention Type DRUG

SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.

Symbicort Turbohaler

2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.

Group Type ACTIVE_COMPARATOR

SYMBICORT® TURBOHALER®

Intervention Type DRUG

Symbicort Turbohaler will be administered per dose and schedule specified in the arm.

SPIROMAX Placebo

Intervention Type DRUG

SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.

Interventions

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Budesonide/Formoterol SPIROMAX®

BF Spiromax will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

SYMBICORT® TURBOHALER®

Symbicort Turbohaler will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

SYMBICORT placebo

SYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

SPIROMAX Placebo

SPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female participants 12 years and older as of the screening visit. Male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only.
* General good health, and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the participant at increased risk during the study.
* Asthma Diagnosis: The asthma diagnosis must be in accordance with the Global Initiative for Asthma (GINA)

Exclusion Criteria

* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that is not resolved within 2 weeks before the screening visit. In addition, the participant must be excluded if such infection occurs between the screening visit and the baseline visit.
* Any asthma exacerbation requiring oral corticosteroids within 1 month of the screening visit. A participant must not have been hospitalized for asthma within 6 months before the screening visit.
* Presence of glaucoma, cataracts, ocular herpes simplex, or malignancy other than basal cell carcinoma.
* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular conditions (for example, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia or coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine conditions (for example, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), gastrointestinal conditions (for example, poorly-controlled peptic ulcer, gastroesophageal reflux disease \[GERD\]), or pulmonary conditions (for example, chronic bronchitis, emphysema, bronchiectasis with the need for treatment, cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition became exacerbated during the study.
Minimum Eligible Age

12 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, M.D.

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 33020

Grieskirchen, , Austria

Site Status

Teva Investigational Site 33019

Linz, , Austria

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Teva Investigational Site 33018

Wels, , Austria

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Teva Investigational Site 37029

Gozée, , Belgium

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Teva Investigational Site 37031

Halen, , Belgium

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Teva Investigational Site 37030

Jambes, , Belgium

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Teva Investigational Site 54056

Brno, , Czechia

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Teva Investigational Site 54061

Hradec Králové, , Czechia

Site Status

Teva Investigational Site 54068

Neratovice, , Czechia

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Teva Investigational Site 54063

Ostrava - Marianske Hory, , Czechia

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Teva Investigational Site 54065

Pilsen, , Czechia

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Teva Investigational Site 54067

Prague, , Czechia

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Teva Investigational Site 54058

Prague, , Czechia

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Teva Investigational Site 54064

Rokycany, , Czechia

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Teva Investigational Site 54059

Strakonice, , Czechia

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Teva Investigational Site 39020

Copenhagen NV, , Denmark

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Teva Investigational Site 39021

Odense, , Denmark

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Teva Investigational Site 40004

Helsinki, , Finland

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Teva Investigational Site 40005

Jyväskylä, , Finland

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Teva Investigational Site 40002

Pori, , Finland

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Teva Investigational Site 40001

Tampere, , Finland

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Teva Investigational Site 40003

Turku, , Finland

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Teva Investigational Site 35088

Brest, , France

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Teva Investigational Site 35089

La Bouëxière, , France

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Teva Investigational Site 35093

Lyon, , France

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Teva Investigational Site 35092

Mûrs-Erigné, , France

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Teva Investigational Site 35090

Nantes, , France

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Teva Investigational Site 35091

Perpignan, , France

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Teva Investigational Site 32243

Berlin, , Germany

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Teva Investigational Site 32255

Berlin, , Germany

Site Status

Teva Investigational Site 32256

Berlin, , Germany

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Teva Investigational Site 32257

Berlin, , Germany

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Teva Investigational Site 32252

Cottbus, , Germany

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Teva Investigational Site 32251

Frankfurt am Main, , Germany

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Teva Investigational Site 32253

Frankfurt am Main, , Germany

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Teva Investigational Site 32254

Gelsenkirchen, , Germany

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Teva Investigational Site 32259

Großhansdorf, , Germany

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Teva Investigational Site 32249

Hamburg, , Germany

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Teva Investigational Site 32246

Leipzig, , Germany

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Teva Investigational Site 32240

Neu-Isenburg, , Germany

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Teva Investigational Site 32244

Neukölln, , Germany

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Teva Investigational Site 32258

Offenbach, , Germany

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Teva Investigational Site 32250

Reinfeld, , Germany

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Teva Investigational Site 32241

Rudersdorf, , Germany

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Teva Investigational Site 32247

Weinheim, , Germany

Site Status

Teva Investigational Site 51075

Balassagyarmat, , Hungary

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Teva Investigational Site 51072

Budapest, , Hungary

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Teva Investigational Site 51067

Budapest, , Hungary

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Teva Investigational Site 51077

Csorna, , Hungary

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Teva Investigational Site 51065

Deszk, , Hungary

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Teva Investigational Site 51071

Kaposvár, , Hungary

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Teva Investigational Site 51073

Kaposvár, , Hungary

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Teva Investigational Site 51068

Komárom, , Hungary

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Teva Investigational Site 51070

Mosdós, , Hungary

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Teva Investigational Site 51076

Tatabánya, , Hungary

Site Status

Teva Investigational Site 51074

Törökbálint, , Hungary

Site Status

Teva Investigational Site 80036

Afula, , Israel

Site Status

Teva Investigational Site 80035

Haifa, , Israel

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Teva Investigational Site 80040

Kfar Saba, , Israel

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Teva Investigational Site 80039

Petah Tikva, , Israel

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Teva Investigational Site 80037

Ramat Gan, , Israel

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Teva Investigational Site 80038

Rehovot, , Israel

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Teva Investigational Site 80041

Ẕerifin, , Israel

Site Status

Teva Investigational Site 30055

Cisanello Pisa, , Italy

Site Status

Teva Investigational Site 30056

Milan, , Italy

Site Status

Teva Investigational Site 30054

Padua, , Italy

Site Status

Teva Investigational Site 38048

Alkmaar, , Netherlands

Site Status

Teva Investigational Site 38049

Leeuwarden, , Netherlands

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Teva Investigational Site 53114

Bialystok, , Poland

Site Status

Teva Investigational Site 53110

Bialystok, , Poland

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Teva Investigational Site 53117

Gdansk, , Poland

Site Status

Teva Investigational Site 53106

Gdansk, , Poland

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Teva Investigational Site 53109

Krakow, , Poland

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Teva Investigational Site 53111

Krakow, , Poland

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Teva Investigational Site 53100

Krakow, , Poland

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Teva Investigational Site 53107

Lodz, , Poland

Site Status

Teva Investigational Site 53102

Lublin, , Poland

Site Status

Teva Investigational Site 53116

Poznan, , Poland

Site Status

Teva Investigational Site 53119

Sopot, , Poland

Site Status

Teva Investigational Site 53103

Strzelce Opolskie, , Poland

Site Status

Teva Investigational Site 53104

Szczecin, , Poland

Site Status

Teva Investigational Site 53105

Tarnów, , Poland

Site Status

Teva Investigational Site 53120

Wroclaw, , Poland

Site Status

Teva Investigational Site 53099

Wroclaw, , Poland

Site Status

Teva Investigational Site 53115

Wroclaw, , Poland

Site Status

Teva Investigational Site 53113

Zabrze, , Poland

Site Status

Teva Investigational Site 53101

Zgierz, , Poland

Site Status

Teva Investigational Site 50179

Kazan', , Russia

Site Status

Teva Investigational Site 50177

Moscow, , Russia

Site Status

Teva Investigational Site 50178

Saint Petersburg, , Russia

Site Status

Teva Investigational Site 50175

Saint Petersburg, , Russia

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Teva Investigational Site 50171

Saint Petersburg, , Russia

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Teva Investigational Site 50172

Saratov, , Russia

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Teva Investigational Site 50173

Tomsk, , Russia

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Teva Investigational Site 50170

Vsevolozhsk, , Russia

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Teva Investigational Site 50174

Yaroslavl, , Russia

Site Status

Teva Investigational Site 31051

Alcorcón, , Spain

Site Status

Teva Investigational Site 31054

Badalona, , Spain

Site Status

Teva Investigational Site 31052

Barcelona, , Spain

Site Status

Teva Investigational Site 31057

Barcelona, , Spain

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Teva Investigational Site 31053

Bilbao, , Spain

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Teva Investigational Site 31058

Madrid, , Spain

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Teva Investigational Site 31056

Pamplona, , Spain

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Teva Investigational Site 31055

Seville, , Spain

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Teva Investigational Site 31061

Vitoria-Gasteiz, , Spain

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Teva Investigational Site 42014

Gothenburg, , Sweden

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Teva Investigational Site 42011

Lund, , Sweden

Site Status

Teva Investigational Site 42012

Stockholm, , Sweden

Site Status

Teva Investigational Site 34024

Chesterfield, , United Kingdom

Site Status

Teva Investigational Site 34026

Coventry, , United Kingdom

Site Status

Teva Investigational Site 34022

Dundee, , United Kingdom

Site Status

Teva Investigational Site 34027

East Sussex, , United Kingdom

Site Status

Teva Investigational Site 34029

Lancashire, , United Kingdom

Site Status

Teva Investigational Site 34028

London, , United Kingdom

Site Status

Countries

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Turkey (Türkiye) Austria Belgium Czechia Denmark Finland France Germany Hungary Israel Italy Netherlands Poland Russia Spain Sweden United Kingdom

References

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Virchow JC, Rodriguez-Roisin R, Papi A, Shah TP, Gopalan G. A randomized, double-blinded, double-dummy efficacy and safety study of budesonide-formoterol Spiromax(R) compared to budesonide-formoterol Turbuhaler(R) in adults and adolescents with persistent asthma. BMC Pulm Med. 2016 Mar 17;16:42. doi: 10.1186/s12890-016-0200-x.

Reference Type DERIVED
PMID: 26987997 (View on PubMed)

Other Identifiers

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BFS-AS-306

Identifier Type: -

Identifier Source: org_study_id