Clinical trial NCT01803555: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Budesonide/Formoterol SPIROMAX®
SYMBICORT® TURBOHALER®
Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-04
Enrollment: 605
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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
timeFrame: Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Secondary outcomes:
measure: Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period
timeFrame: Baseline, Weeks 1 to 12 (averaged over 12 weeks)
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 12
measure: Number of Participants With Signs of Oral Candidiasis (Thrush)
timeFrame: Baseline, Week 4, Week 8, Week 12
measure: Number of Participants With Positive Swab of Oral Candidiasis (Thrush)
timeFrame: Baseline, Week 4, Week 8, Week 12
Other outcomes:
Locations:
city: Grieskirchen
country: Austria
facility: Teva Investigational Site 33020
city: Linz
country: Austria
facility: Teva Investigational Site 33019
city: Wels
country: Austria
facility: Teva Investigational Site 33018
city: Gozee
country: Belgium
facility: Teva Investigational Site 37029
city: Halen
country: Belgium
facility: Teva Investigational Site 37031
city: Jambes
country: Belgium
facility: Teva Investigational Site 37030
city: Brno
country: Czechia
facility: Teva Investigational Site 54056
city: Hradec Kralove
country: Czechia
facility: Teva Investigational Site 54061
city: Neratovice
country: Czechia
facility: Teva Investigational Site 54068
city: Ostrava - Marianske Hory
country: Czechia
facility: Teva Investigational Site 54063
city: Plzen
country: Czechia
facility: Teva Investigational Site 54065
city: Praha
country: Czechia
facility: Teva Investigational Site 54067
city: Praha
country: Czechia
facility: Teva Investigational Site 54058
city: Rokycany
country: Czechia
facility: Teva Investigational Site 54064
city: Strakonice
country: Czechia
facility: Teva Investigational Site 54059
city: Copenhagen NV
country: Denmark
facility: Teva Investigational Site 39020
city: Odense
country: Denmark
facility: Teva Investigational Site 39021
city: Helsinki
country: Finland
facility: Teva Investigational Site 40004
city: Jyvaskyla
country: Finland
facility: Teva Investigational Site 40005
city: Pori
country: Finland
facility: Teva Investigational Site 40002
city: Tampere
country: Finland
facility: Teva Investigational Site 40001
city: Turku
country: Finland
facility: Teva Investigational Site 40003
city: Brest Cedex 2
country: France
facility: Teva Investigational Site 35088
city: La Bouexiere
country: France
facility: Teva Investigational Site 35089
city: Lyon Cedex 04
country: France
facility: Teva Investigational Site 35093
city: Murs Erigne
country: France
facility: Teva Investigational Site 35092
city: Nantes
country: France
facility: Teva Investigational Site 35090
city: Perpignan
country: France
facility: Teva Investigational Site 35091
city: Berlin-Neukolln
country: Germany
facility: Teva Investigational Site 32244
city: Berlin
country: Germany
facility: Teva Investigational Site 32243
city: Berlin
country: Germany
facility: Teva Investigational Site 32255
city: Berlin
country: Germany
facility: Teva Investigational Site 32256
city: Berlin
country: Germany
facility: Teva Investigational Site 32257
city: Cottbus
country: Germany
facility: Teva Investigational Site 32252
city: Frankfurt am Main
country: Germany
facility: Teva Investigational Site 32251
city: Frankfurt/Main
country: Germany
facility: Teva Investigational Site 32253
city: Gelsenkirchen
country: Germany
facility: Teva Investigational Site 32254
city: Grosshansdorf
country: Germany
facility: Teva Investigational Site 32259
city: Hamburg
country: Germany
facility: Teva Investigational Site 32249
city: Leipzig
country: Germany
facility: Teva Investigational Site 32246
city: Neu-Isenburg
country: Germany
facility: Teva Investigational Site 32240
city: Offenbach
country: Germany
facility: Teva Investigational Site 32258
city: Reinfeld
country: Germany
facility: Teva Investigational Site 32250
city: Rudersdorf
country: Germany
facility: Teva Investigational Site 32241
city: Weinheim
country: Germany
facility: Teva Investigational Site 32247
city: Balassagyarmat
country: Hungary
facility: Teva Investigational Site 51075
city: Budapest
country: Hungary
facility: Teva Investigational Site 51072
city: Budapest
country: Hungary
facility: Teva Investigational Site 51067
city: Csorna
country: Hungary
facility: Teva Investigational Site 51077
city: Deszk
country: Hungary
facility: Teva Investigational Site 51065
city: Kaposvar
country: Hungary
facility: Teva Investigational Site 51071
city: Kaposvar
country: Hungary
facility: Teva Investigational Site 51073
city: Komarom
country: Hungary
facility: Teva Investigational Site 51068
city: Mosdos
country: Hungary
facility: Teva Investigational Site 51070
city: Tatabanya
country: Hungary
facility: Teva Investigational Site 51076
city: Torokbalint
country: Hungary
facility: Teva Investigational Site 51074
city: Afula
country: Israel
facility: Teva Investigational Site 80036
city: Haifa
country: Israel
facility: Teva Investigational Site 80035
city: Kfar Saba
country: Israel
facility: Teva Investigational Site 80040
city: Petach Tikva
country: Israel
facility: Teva Investigational Site 80039
city: Ramat Gan
country: Israel
facility: Teva Investigational Site 80037
city: Rehovot
country: Israel
facility: Teva Investigational Site 80038
city: Zerifin
country: Israel
facility: Teva Investigational Site 80041
city: Cisanello Pisa
country: Italy
facility: Teva Investigational Site 30055
city: Milano
country: Italy
facility: Teva Investigational Site 30056
city: Padova
country: Italy
facility: Teva Investigational Site 30054
city: Alkmaar
country: Netherlands
facility: Teva Investigational Site 38048
city: Leeuwarden
country: Netherlands
facility: Teva Investigational Site 38049
city: Bialystok
country: Poland
facility: Teva Investigational Site 53114
city: Bialystok
country: Poland
facility: Teva Investigational Site 53110
city: Gdansk
country: Poland
facility: Teva Investigational Site 53117
city: Gdansk
country: Poland
facility: Teva Investigational Site 53106
city: Krakow
country: Poland
facility: Teva Investigational Site 53109
city: Krakow
country: Poland
facility: Teva Investigational Site 53111
city: Krakow
country: Poland
facility: Teva Investigational Site 53100
city: Lodz
country: Poland
facility: Teva Investigational Site 53107
city: Lublin
country: Poland
facility: Teva Investigational Site 53102
city: Poznan
country: Poland
facility: Teva Investigational Site 53116
city: Sopot
country: Poland
facility: Teva Investigational Site 53119
city: Strzelce Opolskie
country: Poland
facility: Teva Investigational Site 53103
city: Szczecin
country: Poland
facility: Teva Investigational Site 53104
city: Tarnow
country: Poland
facility: Teva Investigational Site 53105
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53120
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53099
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53115
city: Zabrze
country: Poland
facility: Teva Investigational Site 53113
city: Zgierz
country: Poland
facility: Teva Investigational Site 53101
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50179
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50177
city: Saint Petersburg
country: Russian Federation
facility: Teva Investigational Site 50171
city: Saint-Petersburg
country: Russian Federation
facility: Teva Investigational Site 50175
city: Saratov
country: Russian Federation
facility: Teva Investigational Site 50172
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50178
city: Tomsk
country: Russian Federation
facility: Teva Investigational Site 50173
city: Vsevolozhsk
country: Russian Federation
facility: Teva Investigational Site 50170
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 50174
city: Alcorcon
country: Spain
facility: Teva Investigational Site 31051
city: Badalona
country: Spain
facility: Teva Investigational Site 31054
city: Barcelona
country: Spain
facility: Teva Investigational Site 31052
city: Barcelona
country: Spain
facility: Teva Investigational Site 31057
city: Bilbao
country: Spain
facility: Teva Investigational Site 31053
city: Madrid
country: Spain
facility: Teva Investigational Site 31058
city: Pamplona
country: Spain
facility: Teva Investigational Site 31056
city: Sevilla
country: Spain
facility: Teva Investigational Site 31055
city: Vitoria
country: Spain
facility: Teva Investigational Site 31061
city: Goteborg
country: Sweden
facility: Teva Investigational Site 42014
city: Lund
country: Sweden
facility: Teva Investigational Site 42011
city: Stockholm
country: Sweden
facility: Teva Investigational Site 42012
city: Chesterfield
country: United Kingdom
facility: Teva Investigational Site 34024
city: Coventry
country: United Kingdom
facility: Teva Investigational Site 34026
city: Dundee
country: United Kingdom
facility: Teva Investigational Site 34022
city: East Sussex
country: United Kingdom
facility: Teva Investigational Site 34027
city: Lancashire
country: United Kingdom
facility: Teva Investigational Site 34029
city: London
country: United Kingdom
facility: Teva Investigational Site 34028
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, M.D.
role: STUDY_DIRECTOR
References:
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.