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AsthmaPhase 3NCT01803555

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

A Phase 3 study testing Budesonide/Formoterol SPIROMAX® and SYMBICORT® TURBOHALER® in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 114 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Asthma
What is being tested?
Budesonide/Formoterol SPIROMAX® and SYMBICORT® TURBOHALER®
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
605 participants
Where
114 sitesin 16 countries
Study dates
4 Jul 2013to 20 Mar 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

114 sites in 16 countries.

114 sites in 16 countries

Poland19 sites

  • Teva Investigational Site 53114

    Bialystok, 15-276

  • Teva Investigational Site 53110

    Bialystok, 15-430

  • Teva Investigational Site 53117

    Gdansk, 80-433

  • Teva Investigational Site 53106

    Gdansk, 80-847

  • Teva Investigational Site 53109

    Krakow, 31-011

  • Teva Investigational Site 53111

    Krakow, 31-023

  • Teva Investigational Site 53100

    Krakow, 31-159

  • Teva Investigational Site 53107

    Lodz, 90-153

  • Teva Investigational Site 53102

    Lublin, 20-093

  • Teva Investigational Site 53116

    Poznan, 60-214

  • Teva Investigational Site 53119

    Sopot, 81-741

  • Teva Investigational Site 53103

    Strzelce Opolskie, 47-100

  • Teva Investigational Site 53104

    Szczecin, 71-124

  • Teva Investigational Site 53105

    Tarnów, 33-100

  • Teva Investigational Site 53120

    Wroclaw, 51-343

  • Teva Investigational Site 53099

    Wroclaw, 53-201

  • Teva Investigational Site 53115

    Wroclaw, 53-301

  • Teva Investigational Site 53113

    Zabrze, 41-800

  • Teva Investigational Site 53101

    Zgierz, 95-100

Other trials in Poland

Germany17 sites

  • Teva Investigational Site 32243

    Berlin, 10367

  • Teva Investigational Site 32255

    Berlin, 10717

  • Teva Investigational Site 32256

    Berlin, 10787

  • Teva Investigational Site 32257

    Berlin, 12687

  • Teva Investigational Site 32252

    Cottbus, 03050

  • Teva Investigational Site 32251

    Frankfurt am Main, 60318

  • Teva Investigational Site 32253

    Frankfurt am Main, 60389

  • Teva Investigational Site 32254

    Gelsenkirchen, 45879

  • Teva Investigational Site 32259

    Großhansdorf, 22927

  • Teva Investigational Site 32249

    Hamburg, 20354

  • Teva Investigational Site 32246

    Leipzig, 4357

  • Teva Investigational Site 32240

    Neu-Isenburg, 63263

  • Teva Investigational Site 32244

    Neukölln, 12043

  • Teva Investigational Site 32258

    Offenbach, 63071

  • Teva Investigational Site 32250

    Reinfeld, 23858

  • Teva Investigational Site 32241

    Rüdersdorf, 15562

  • Teva Investigational Site 32247

    Weinheim, 69469

Other trials in Germany

Hungary11 sites

  • Teva Investigational Site 51075

    Balassagyarmat, 2660

  • Teva Investigational Site 51072

    Budapest, 1134

  • Teva Investigational Site 51067

    Budapest, 2310

  • Teva Investigational Site 51077

    Csorna, 9300

  • Teva Investigational Site 51065

    Deszk, 6772

  • Teva Investigational Site 51071

    Kaposvár, 7400

  • Teva Investigational Site 51073

    Kaposvár, 7400

  • Teva Investigational Site 51068

    Komárom, 2900

  • Teva Investigational Site 51070

    Mosdós, 7257

  • Teva Investigational Site 51076

    Tatabánya, 2800

  • Teva Investigational Site 51074

    Törökbálint, 2045

Other trials in Hungary

Czechia9 sites

  • Teva Investigational Site 54056

    Brno, 602 00

  • Teva Investigational Site 54061

    Hradec Králové, 500 05

  • Teva Investigational Site 54068

    Neratovice, 27711

  • Teva Investigational Site 54063

    Ostrava - Marianske Hory, 709 00

  • Teva Investigational Site 54065

    Pilsen, 301 00

  • Teva Investigational Site 54067

    Prague, 142 00

  • Teva Investigational Site 54058

    Prague, 186 00

  • Teva Investigational Site 54064

    Rokycany, 337 22

  • Teva Investigational Site 54059

    Strakonice, 386 01

Other trials in Czechia

Russia9 sites

  • Teva Investigational Site 50179

    Kazan', 420015

  • Teva Investigational Site 50177

    Moscow, 125367

  • Teva Investigational Site 50178

    Saint Petersburg, 193231

  • Teva Investigational Site 50175

    Saint Petersburg, 194354

  • Teva Investigational Site 50171

    Saint Petersburg, 197022

  • Teva Investigational Site 50172

    Saratov, 410028

  • Teva Investigational Site 50173

    Tomsk, 634050

  • Teva Investigational Site 50170

    Vsevolozhsk, 188640

  • Teva Investigational Site 50174

    Yaroslavl, 150003

Other trials in Russia

Spain9 sites

  • Teva Investigational Site 31051

    Alcorcón, 28922

  • Teva Investigational Site 31054

    Badalona, 08916

  • Teva Investigational Site 31052

    Barcelona, 08036

  • Teva Investigational Site 31057

    Barcelona, 08041

  • Teva Investigational Site 31053

    Bilbao, 48013

  • Teva Investigational Site 31058

    Madrid, 28006

  • Teva Investigational Site 31056

    Pamplona, 31008

  • Teva Investigational Site 31055

    Seville, 41013

  • Teva Investigational Site 31061

    Vitoria-Gasteiz, 01004

Other trials in Spain

Israel7 sites

  • Teva Investigational Site 80036

    Afula, 18101

  • Teva Investigational Site 80035

    Haifa, 31096

  • Teva Investigational Site 80040

    Kfar Saba, 44281

  • Teva Investigational Site 80039

    Petah Tikva, 49100

  • Teva Investigational Site 80037

    Ramat Gan, 5262160

  • Teva Investigational Site 80038

    Rehovot, 76100

  • Teva Investigational Site 80041

    Tsrifin, 70300

Other trials in Israel

France6 sites

  • Teva Investigational Site 35088

    Brest, 29609

  • Teva Investigational Site 35089

    La Bouëxière, 35340

  • Teva Investigational Site 35093

    Lyon, 69317

  • Teva Investigational Site 35092

    Mûrs-Erigné, 49610

  • Teva Investigational Site 35090

    Nantes, 44200

  • Teva Investigational Site 35091

    Perpignan, 66000

Other trials in France

United Kingdom6 sites

  • Teva Investigational Site 34024

    Chesterfield, S40 4AA

  • Teva Investigational Site 34026

    Coventry, CV6 4DD

  • Teva Investigational Site 34022

    Dundee, DD1 4HJ

  • Teva Investigational Site 34027

    East Sussex, TN40 1JJ

  • Teva Investigational Site 34029

    Lancashire, FY4 3AD

  • Teva Investigational Site 34028

    London, EC1M 6BQ

Other trials in United Kingdom

Finland5 sites

  • Teva Investigational Site 40004

    Helsinki, 00290

  • Teva Investigational Site 40005

    Jyväskylä, 40100

  • Teva Investigational Site 40002

    Pori, 28500

  • Teva Investigational Site 40001

    Tampere, 33521

  • Teva Investigational Site 40003

    Turku, 20100

Other trials in Finland

Austria3 sites

  • Teva Investigational Site 33020

    Grieskirchen, 4710

  • Teva Investigational Site 33019

    Linz, 4020

  • Teva Investigational Site 33018

    Wels, 4600

Other trials in Austria

Belgium3 sites

  • Teva Investigational Site 37029

    Gozée, 6534

  • Teva Investigational Site 37031

    Halen, 3545

  • Teva Investigational Site 37030

    Jambes, 5100

Other trials in Belgium

Italy3 sites

  • Teva Investigational Site 30055

    Cisanello Pisa, 56124

  • Teva Investigational Site 30056

    Milan, 20142

  • Teva Investigational Site 30054

    Padova, 35122

Other trials in Italy

Sweden3 sites

  • Teva Investigational Site 42014

    Gothenburg, 413 45

  • Teva Investigational Site 42011

    Lund, 222 41

  • Teva Investigational Site 42012

    Stockholm, 141 86

Other trials in Sweden

Denmark2 sites

  • Teva Investigational Site 39020

    Copenhagen NV, 2400

  • Teva Investigational Site 39021

    Odense, 5000

Other trials in Denmark

Netherlands2 sites

  • Teva Investigational Site 38048

    Alkmaar, 1815 JD

  • Teva Investigational Site 38049

    Leeuwarden, 8901 BR

Other trials in Netherlands

About this study

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

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.

Conditions
Asthma
Being tested
Budesonide/Formoterol SPIROMAX®, SYMBICORT® TURBOHALER®, SYMBICORT placebo, SPIROMAX Placebo
Keywords
Budesonide/Formoterol SPIROMAX®, SYMBICORT® TURBOHALER®, Asthma
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide/Formoterol SPIROMAX®Drug

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

  • SYMBICORT® TURBOHALER®Drug

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

  • SYMBICORT placeboDrug

    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.

  • SPIROMAX PlaceboDrug

    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.

Study groups in NCT01803555
Study groupRoleWhat they receive
BF SpiromaxExperimental2 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.
Receives: Drug: Budesonide/Formoterol SPIROMAX®; Drug: SYMBICORT placebo
Symbicort TurbohalerActive comparator2 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.
Receives: Drug: SYMBICORT® TURBOHALER®; Drug: SPIROMAX Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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. Baseline trough morning PEF was 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 consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline [Day 1]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline [Day 1]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.

    Measured: Baseline, Weeks 1 to 12 (averaged over 12 weeks)

Secondary outcomes (4)

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

    PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Baseline was defined as the average value of the recorded (nonmissing) assessments over the 7 days prior to randomization. For postdose weekly average of evening PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of evening PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.

    Measured: Baseline, Weeks 1 to 12 (averaged over 12 weeks)

  2. 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. A 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'.

    Measured: Baseline up to Week 12

  3. Number of Participants With Signs of Oral Candidiasis (Thrush)

    Examinations were performed by a qualified professional.

    Measured: Baseline, Week 4, Week 8, Week 12

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

    Swab samples were collected by a qualified professional.

    Measured: Baseline, Week 4, Week 8, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2013 (estimated)
  2. Study start4 Jul 2013
  3. Primary completion20 Mar 2014
  4. Study completion20 Mar 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01803555
Sponsor's protocol ID
BFS-AS-306
Status last verified
Mar 2023
First submitted
28 Feb 2013
Last updated
8 Dec 2023
Data monitoring committee
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 26987997

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide/Formoterol SPIROMAX® and SYMBICORT® TURBOHALER® in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 114 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 114 sites in Poland, Germany, Hungary, Czechia, Russia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline, Weeks 1 to 12 (averaged over 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01803555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.

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