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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Budesonide/Formoterol SPIROMAX®

SYMBICORT® TURBOHALER®

SYMBICORT placebo

SPIROMAX Placebo

About this trial

This is an interventional treatment trial for Asthma focused on measuring Budesonide/Formoterol SPIROMAX®, SYMBICORT® TURBOHALER®, Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

NOTE: Other inclusion and exclusion criteria may apply.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BF Spiromax

Symbicort Turbohaler

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Morning PEF will be determined in the morning, before administration of IMP or rescue medications. Baseline trough morning PEF is defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization will consist of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day post-randomization will consist of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For post-dose weekly average of trough morning PEF measurements, the values will be the averages based on the available data for that week. The averages will be calculated as the sum of morning PEF values divided by the number of non-missing assessments.

Secondary Outcome Measures

Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period

Peak Expiratory Flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Analysis will be performed using MMRM with effects due to baseline weekly average PM PEF, gender, age, treatment, time, and treatment-by-time interaction.

Number of Participants With Adverse Events (AEs)

An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) will be 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.

Number of Participants With Signs of Oral Candidiasis (Thrush)

Examinations will be performed by a qualified professional.

Number of Participants With Positive Swab of Oral Candidiasis (Thrush)

Swab samples will be collected by a qualified professional.

Full Information

NCT ID

NCT01803555

First Posted

February 28, 2013

Last Updated

March 28, 2022

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01803555

Brief Title

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

Official Title

A 12-Week Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX(R) 160/4.5 mcg Inhalation Powder Versus SYMBICORT(R) TURBOHALER(R) 200/6 mcg in Adult and Adolescent Patients With Persistent Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

July 4, 2013 (Actual)

Primary Completion Date

March 20, 2014 (Actual)

Study Completion Date

March 20, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Budesonide/Formoterol SPIROMAX®, SYMBICORT® TURBOHALER®, Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

605 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BF Spiromax

Arm Type

Experimental

Arm Description

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.

Arm Title

Symbicort Turbohaler

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Budesonide/Formoterol SPIROMAX®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SYMBICORT® TURBOHALER®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

SYMBICORT placebo

Intervention Description

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

Intervention Name(s)

SPIROMAX Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

Description

Time Frame

Baseline, Weeks 1 to 12

Secondary Outcome Measure Information:

Title

Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period

Description

Time Frame

Baseline, Weeks 1 to 12

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 12

Title

Number of Participants With Signs of Oral Candidiasis (Thrush)

Description

Examinations will be performed by a qualified professional.

Time Frame

Baseline, Week 4, Week 8, Week 12

Title

Number of Participants With Positive Swab of Oral Candidiasis (Thrush)

Description

Swab samples will be collected by a qualified professional.

Time Frame

Baseline, Week 4, Week 8, Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. NOTE: Other inclusion and exclusion criteria may apply.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, M.D.

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 33020

City

Grieskirchen

ZIP/Postal Code

4710

Country

Austria

Facility Name

Teva Investigational Site 33019

City

Linz

ZIP/Postal Code

4020

Country

Austria

Facility Name

Teva Investigational Site 33018

City

Wels

ZIP/Postal Code

4600

Country

Austria

Facility Name

Teva Investigational Site 37029

City

Gozee

ZIP/Postal Code

6534

Country

Belgium

Facility Name

Teva Investigational Site 37031

City

Halen

ZIP/Postal Code

3545

Country

Belgium

Facility Name

Teva Investigational Site 37030

City

Jambes

ZIP/Postal Code

5100

Country

Belgium

Facility Name

Teva Investigational Site 54056

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Teva Investigational Site 54061

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Teva Investigational Site 54068

City

Neratovice

ZIP/Postal Code

27711

Country

Czechia

Facility Name

Teva Investigational Site 54063

City

Ostrava - Marianske Hory

ZIP/Postal Code

709 00

Country

Czechia

Facility Name

Teva Investigational Site 54065

City

Plzen

ZIP/Postal Code

301 00

Country

Czechia

Facility Name

Teva Investigational Site 54067

City

Praha

ZIP/Postal Code

142 00

Country

Czechia

Facility Name

Teva Investigational Site 54058

City

Praha

ZIP/Postal Code

186 00

Country

Czechia

Facility Name

Teva Investigational Site 54064

City

Rokycany

ZIP/Postal Code

337 22

Country

Czechia

Facility Name

Teva Investigational Site 54059

City

Strakonice

ZIP/Postal Code

386 01

Country

Czechia

Facility Name

Teva Investigational Site 39020

City

Copenhagen NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Teva Investigational Site 39021

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Teva Investigational Site 40004

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

Teva Investigational Site 40005

City

Jyvaskyla

ZIP/Postal Code

40100

Country

Finland

Facility Name

Teva Investigational Site 40002

City

Pori

ZIP/Postal Code

28500

Country

Finland

Facility Name

Teva Investigational Site 40001

City

Tampere

ZIP/Postal Code

33521

Country

Finland

Facility Name

Teva Investigational Site 40003

City

Turku

ZIP/Postal Code

20100

Country

Finland

Facility Name

Teva Investigational Site 35088

City

Brest Cedex 2

ZIP/Postal Code

29609

Country

France

Facility Name

Teva Investigational Site 35089

City

La Bouexiere

ZIP/Postal Code

35340

Country

France

Facility Name

Teva Investigational Site 35093

City

Lyon Cedex 04

ZIP/Postal Code

69317

Country

France

Facility Name

Teva Investigational Site 35092

City

Murs Erigne

ZIP/Postal Code

49610

Country

France

Facility Name

Teva Investigational Site 35090

City

Nantes

ZIP/Postal Code

44200

Country

France

Facility Name

Teva Investigational Site 35091

City

Perpignan

ZIP/Postal Code

66000

Country

France

Facility Name

Teva Investigational Site 32244

City

Berlin-Neukolln

ZIP/Postal Code

12043

Country

Germany

Facility Name

Teva Investigational Site 32243

City

Berlin

ZIP/Postal Code

10367

Country

Germany

Facility Name

Teva Investigational Site 32255

City

Berlin

ZIP/Postal Code

10717

Country

Germany

Facility Name

Teva Investigational Site 32256

City

Berlin

ZIP/Postal Code

10787

Country

Germany

Facility Name

Teva Investigational Site 32257

City

Berlin

ZIP/Postal Code

12687

Country

Germany

Facility Name

Teva Investigational Site 32252

City

Cottbus

ZIP/Postal Code

03050

Country

Germany

Facility Name

Teva Investigational Site 32251

City

Frankfurt am Main

ZIP/Postal Code

60318

Country

Germany

Facility Name

Teva Investigational Site 32253

City

Frankfurt/Main

ZIP/Postal Code

60389

Country

Germany

Facility Name

Teva Investigational Site 32254

City

Gelsenkirchen

ZIP/Postal Code

45879

Country

Germany

Facility Name

Teva Investigational Site 32259

City

Grosshansdorf

ZIP/Postal Code

22927

Country

Germany

Facility Name

Teva Investigational Site 32249

City

Hamburg

ZIP/Postal Code

20354

Country

Germany

Facility Name

Teva Investigational Site 32246

City

Leipzig

ZIP/Postal Code

4357

Country

Germany

Facility Name

Teva Investigational Site 32240

City

Neu-Isenburg

ZIP/Postal Code

63263

Country

Germany

Facility Name

Teva Investigational Site 32258

City

Offenbach

ZIP/Postal Code

63071

Country

Germany

Facility Name

Teva Investigational Site 32250

City

Reinfeld

ZIP/Postal Code

23858

Country

Germany

Facility Name

Teva Investigational Site 32241

City

Rudersdorf

ZIP/Postal Code

15562

Country

Germany

Facility Name

Teva Investigational Site 32247

City

Weinheim

ZIP/Postal Code

69469

Country

Germany

Facility Name

Teva Investigational Site 51075

City

Balassagyarmat

ZIP/Postal Code

2660

Country

Hungary

Facility Name

Teva Investigational Site 51072

City

Budapest

ZIP/Postal Code

1134

Country

Hungary

Facility Name

Teva Investigational Site 51067

City

Budapest

ZIP/Postal Code

2310

Country

Hungary

Facility Name

Teva Investigational Site 51077

City

Csorna

ZIP/Postal Code

9300

Country

Hungary

Facility Name

Teva Investigational Site 51065

City

Deszk

ZIP/Postal Code

6772

Country

Hungary

Facility Name

Teva Investigational Site 51071

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Teva Investigational Site 51073

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Teva Investigational Site 51068

City

Komarom

ZIP/Postal Code

2900

Country

Hungary

Facility Name

Teva Investigational Site 51070

City

Mosdos

ZIP/Postal Code

7257

Country

Hungary

Facility Name

Teva Investigational Site 51076

City

Tatabanya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

Teva Investigational Site 51074

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Teva Investigational Site 80036

City

Afula

ZIP/Postal Code

18101

Country

Israel

Facility Name

Teva Investigational Site 80035

City

Haifa

ZIP/Postal Code

31096

Country

Israel

Facility Name

Teva Investigational Site 80040

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Teva Investigational Site 80039

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Teva Investigational Site 80037

City

Ramat Gan

ZIP/Postal Code

5262160

Country

Israel

Facility Name

Teva Investigational Site 80038

City

Rehovot

ZIP/Postal Code

76100

Country

Israel

Facility Name

Teva Investigational Site 80041

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Teva Investigational Site 30055

City

Cisanello Pisa

ZIP/Postal Code

56124

Country

Italy

Facility Name

Teva Investigational Site 30056

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Teva Investigational Site 30054

City

Padova

ZIP/Postal Code

35122

Country

Italy

Facility Name

Teva Investigational Site 38048

City

Alkmaar

ZIP/Postal Code

1815 JD

Country

Netherlands

Facility Name

Teva Investigational Site 38049

City

Leeuwarden

ZIP/Postal Code

8901 BR

Country

Netherlands

Facility Name

Teva Investigational Site 53114

City

Bialystok

ZIP/Postal Code

15-276

Country

Poland

Facility Name

Teva Investigational Site 53110

City

Bialystok

ZIP/Postal Code

15-430

Country

Poland

Facility Name

Teva Investigational Site 53117

City

Gdansk

ZIP/Postal Code

80-433

Country

Poland

Facility Name

Teva Investigational Site 53106

City

Gdansk

ZIP/Postal Code

80-847

Country

Poland

Facility Name

Teva Investigational Site 53109

City

Krakow

ZIP/Postal Code

31-011

Country

Poland

Facility Name

Teva Investigational Site 53111

City

Krakow

ZIP/Postal Code

31-023

Country

Poland

Facility Name

Teva Investigational Site 53100

City

Krakow

ZIP/Postal Code

31-159

Country

Poland

Facility Name

Teva Investigational Site 53107

City

Lodz

ZIP/Postal Code

90-153

Country

Poland

Facility Name

Teva Investigational Site 53102

City

Lublin

ZIP/Postal Code

20-093

Country

Poland

Facility Name

Teva Investigational Site 53116

City

Poznan

ZIP/Postal Code

60-214

Country

Poland

Facility Name

Teva Investigational Site 53119

City

Sopot

ZIP/Postal Code

81-741

Country

Poland

Facility Name

Teva Investigational Site 53103

City

Strzelce Opolskie

ZIP/Postal Code

47-100

Country

Poland

Facility Name

Teva Investigational Site 53104

City

Szczecin

ZIP/Postal Code

71-124

Country

Poland

Facility Name

Teva Investigational Site 53105

City

Tarnow

ZIP/Postal Code

33-100

Country

Poland

Facility Name

Teva Investigational Site 53120

City

Wroclaw

ZIP/Postal Code

51-343

Country

Poland

Facility Name

Teva Investigational Site 53099

City

Wroclaw

ZIP/Postal Code

53-201

Country

Poland

Facility Name

Teva Investigational Site 53115

City

Wroclaw

ZIP/Postal Code

53-301

Country

Poland

Facility Name

Teva Investigational Site 53113

City

Zabrze

ZIP/Postal Code

41-800

Country

Poland

Facility Name

Teva Investigational Site 53101

City

Zgierz

ZIP/Postal Code

95-100

Country

Poland

Facility Name

Teva Investigational Site 50179

City

Kazan

ZIP/Postal Code

420015

Country

Russian Federation

Facility Name

Teva Investigational Site 50177

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Teva Investigational Site 50171

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Teva Investigational Site 50175

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

Teva Investigational Site 50172

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Teva Investigational Site 50178

City

St. Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

Teva Investigational Site 50173

City

Tomsk

ZIP/Postal Code

634050

Country

Russian Federation

Facility Name

Teva Investigational Site 50170

City

Vsevolozhsk

ZIP/Postal Code

188640

Country

Russian Federation

Facility Name

Teva Investigational Site 50174

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Teva Investigational Site 31051

City

Alcorcon

ZIP/Postal Code

28922

Country

Spain

Facility Name

Teva Investigational Site 31054

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Teva Investigational Site 31052

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Teva Investigational Site 31057

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Teva Investigational Site 31053

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Teva Investigational Site 31058

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Teva Investigational Site 31056

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

Teva Investigational Site 31055

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Teva Investigational Site 31061

City

Vitoria

ZIP/Postal Code

01004

Country

Spain

Facility Name

Teva Investigational Site 42014

City

Goteborg

ZIP/Postal Code

413 45

Country

Sweden

Facility Name

Teva Investigational Site 42011

City

Lund

ZIP/Postal Code

222 41

Country

Sweden

Facility Name

Teva Investigational Site 42012

City

Stockholm

ZIP/Postal Code

141 86

Country

Sweden

Facility Name

Teva Investigational Site 34024

City

Chesterfield

ZIP/Postal Code

S40 4AA

Country

United Kingdom

Facility Name

Teva Investigational Site 34026

City

Coventry

ZIP/Postal Code

CV6 4DD

Country

United Kingdom

Facility Name

Teva Investigational Site 34022

City

Dundee

ZIP/Postal Code

DD1 4HJ

Country

United Kingdom

Facility Name

Teva Investigational Site 34027

City

East Sussex

ZIP/Postal Code

TN40 1JJ

Country

United Kingdom

Facility Name

Teva Investigational Site 34029

City

Lancashire

ZIP/Postal Code

FY4 3AD

Country

United Kingdom

Facility Name

Teva Investigational Site 34028

City

London

ZIP/Postal Code

EC1M 6BQ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Citations:

PubMed Identifier

26987997

Citation

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.

Results Reference

derived

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

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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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