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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01803555
• Other study ID #: BFS-AS-306
• Status: Completed
• Phase: Phase 3
• Start date: July 4, 2013
• Est. completion date: March 20, 2014

Study information

• Verified date: March 2023
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 605
• Est. completion date: March 20, 2014
• Est. primary completion date: March 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/Formoterol SPIROMAX®
BF Spiromax will be administered per dose and schedule specified in the arm.
• SYMBICORT® TURBOHALER®
Symbicort Turbohaler will be administered per dose and schedule specified in the arm.
• 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.
• 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.

Locations

Country	Name	City	State
Austria	Teva Investigational Site 33020	Grieskirchen
Austria	Teva Investigational Site 33019	Linz
Austria	Teva Investigational Site 33018	Wels
Belgium	Teva Investigational Site 37029	Gozee
Belgium	Teva Investigational Site 37031	Halen
Belgium	Teva Investigational Site 37030	Jambes
Czechia	Teva Investigational Site 54056	Brno
Czechia	Teva Investigational Site 54061	Hradec Kralove
Czechia	Teva Investigational Site 54068	Neratovice
Czechia	Teva Investigational Site 54063	Ostrava - Marianske Hory
Czechia	Teva Investigational Site 54065	Plzen
Czechia	Teva Investigational Site 54058	Praha
Czechia	Teva Investigational Site 54067	Praha
Czechia	Teva Investigational Site 54064	Rokycany
Czechia	Teva Investigational Site 54059	Strakonice
Denmark	Teva Investigational Site 39020	Copenhagen NV
Denmark	Teva Investigational Site 39021	Odense
Finland	Teva Investigational Site 40004	Helsinki
Finland	Teva Investigational Site 40005	Jyvaskyla
Finland	Teva Investigational Site 40002	Pori
Finland	Teva Investigational Site 40001	Tampere
Finland	Teva Investigational Site 40003	Turku
France	Teva Investigational Site 35088	Brest Cedex 2
France	Teva Investigational Site 35089	La Bouexiere
France	Teva Investigational Site 35093	Lyon Cedex 04
France	Teva Investigational Site 35092	Murs Erigne
France	Teva Investigational Site 35090	Nantes
France	Teva Investigational Site 35091	Perpignan
Germany	Teva Investigational Site 32243	Berlin
Germany	Teva Investigational Site 32255	Berlin
Germany	Teva Investigational Site 32256	Berlin
Germany	Teva Investigational Site 32257	Berlin
Germany	Teva Investigational Site 32244	Berlin-Neukolln
Germany	Teva Investigational Site 32252	Cottbus
Germany	Teva Investigational Site 32251	Frankfurt am Main
Germany	Teva Investigational Site 32253	Frankfurt/Main
Germany	Teva Investigational Site 32254	Gelsenkirchen
Germany	Teva Investigational Site 32259	Grosshansdorf
Germany	Teva Investigational Site 32249	Hamburg
Germany	Teva Investigational Site 32246	Leipzig
Germany	Teva Investigational Site 32240	Neu-Isenburg
Germany	Teva Investigational Site 32258	Offenbach
Germany	Teva Investigational Site 32250	Reinfeld
Germany	Teva Investigational Site 32241	Rudersdorf
Germany	Teva Investigational Site 32247	Weinheim
Hungary	Teva Investigational Site 51075	Balassagyarmat
Hungary	Teva Investigational Site 51067	Budapest
Hungary	Teva Investigational Site 51072	Budapest
Hungary	Teva Investigational Site 51077	Csorna
Hungary	Teva Investigational Site 51065	Deszk
Hungary	Teva Investigational Site 51071	Kaposvar
Hungary	Teva Investigational Site 51073	Kaposvar
Hungary	Teva Investigational Site 51068	Komarom
Hungary	Teva Investigational Site 51070	Mosdos
Hungary	Teva Investigational Site 51076	Tatabanya
Hungary	Teva Investigational Site 51074	Torokbalint
Israel	Teva Investigational Site 80036	Afula
Israel	Teva Investigational Site 80035	Haifa
Israel	Teva Investigational Site 80040	Kfar Saba
Israel	Teva Investigational Site 80039	Petach Tikva
Israel	Teva Investigational Site 80037	Ramat Gan
Israel	Teva Investigational Site 80038	Rehovot
Israel	Teva Investigational Site 80041	Zerifin
Italy	Teva Investigational Site 30055	Cisanello Pisa
Italy	Teva Investigational Site 30056	Milano
Italy	Teva Investigational Site 30054	Padova
Netherlands	Teva Investigational Site 38048	Alkmaar
Netherlands	Teva Investigational Site 38049	Leeuwarden
Poland	Teva Investigational Site 53110	Bialystok
Poland	Teva Investigational Site 53114	Bialystok
Poland	Teva Investigational Site 53106	Gdansk
Poland	Teva Investigational Site 53117	Gdansk
Poland	Teva Investigational Site 53100	Krakow
Poland	Teva Investigational Site 53109	Krakow
Poland	Teva Investigational Site 53111	Krakow
Poland	Teva Investigational Site 53107	Lodz
Poland	Teva Investigational Site 53102	Lublin
Poland	Teva Investigational Site 53116	Poznan
Poland	Teva Investigational Site 53119	Sopot
Poland	Teva Investigational Site 53103	Strzelce Opolskie
Poland	Teva Investigational Site 53104	Szczecin
Poland	Teva Investigational Site 53105	Tarnow
Poland	Teva Investigational Site 53099	Wroclaw
Poland	Teva Investigational Site 53115	Wroclaw
Poland	Teva Investigational Site 53120	Wroclaw
Poland	Teva Investigational Site 53113	Zabrze
Poland	Teva Investigational Site 53101	Zgierz
Russian Federation	Teva Investigational Site 50179	Kazan
Russian Federation	Teva Investigational Site 50177	Moscow
Russian Federation	Teva Investigational Site 50171	Saint Petersburg
Russian Federation	Teva Investigational Site 50175	Saint-Petersburg
Russian Federation	Teva Investigational Site 50172	Saratov
Russian Federation	Teva Investigational Site 50178	St. Petersburg
Russian Federation	Teva Investigational Site 50173	Tomsk
Russian Federation	Teva Investigational Site 50170	Vsevolozhsk
Russian Federation	Teva Investigational Site 50174	Yaroslavl
Spain	Teva Investigational Site 31051	Alcorcon
Spain	Teva Investigational Site 31054	Badalona
Spain	Teva Investigational Site 31052	Barcelona
Spain	Teva Investigational Site 31057	Barcelona
Spain	Teva Investigational Site 31053	Bilbao
Spain	Teva Investigational Site 31058	Madrid
Spain	Teva Investigational Site 31056	Pamplona
Spain	Teva Investigational Site 31055	Sevilla
Spain	Teva Investigational Site 31061	Vitoria
Sweden	Teva Investigational Site 42014	Goteborg
Sweden	Teva Investigational Site 42011	Lund
Sweden	Teva Investigational Site 42012	Stockholm
United Kingdom	Teva Investigational Site 34024	Chesterfield
United Kingdom	Teva Investigational Site 34026	Coventry
United Kingdom	Teva Investigational Site 34022	Dundee
United Kingdom	Teva Investigational Site 34027	East Sussex
United Kingdom	Teva Investigational Site 34029	Lancashire
United Kingdom	Teva Investigational Site 34028	London

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

Austria,  Belgium,  Czechia,  Denmark,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Netherlands,  Poland,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Secondary	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.	Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Secondary	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'.	Baseline up to Week 12
Secondary	Number of Participants With Signs of Oral Candidiasis (Thrush)	Examinations were performed by a qualified professional.	Baseline, Week 4, Week 8, Week 12
Secondary	Number of Participants With Positive Swab of Oral Candidiasis (Thrush)	Swab samples were collected by a qualified professional.	Baseline, Week 4, Week 8, Week 12