Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®
- Conditions
- Asthma
- Interventions
- Drug: Budesonide/Formoterol SPIROMAX®Drug: SPIROMAX Placebo
- Registration Number
- NCT01803555
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 605
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Symbicort Turbohaler 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. BF Spiromax Budesonide/Formoterol 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. Symbicort Turbohaler SPIROMAX Placebo 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. BF Spiromax SYMBICORT placebo 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.
- Primary Outcome Measures
Name Time Method 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 Baseline, Weeks 1 to 12 (averaged over 12 weeks) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Signs of Oral Candidiasis (Thrush) Baseline, Week 4, Week 8, Week 12 Examinations were performed by a qualified professional.
Number of Participants With Positive Swab of Oral Candidiasis (Thrush) Baseline, Week 4, Week 8, Week 12 Swab samples were collected by a qualified professional.
Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period Baseline, Weeks 1 to 12 (averaged over 12 weeks) 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.
Number of Participants With Adverse Events (AEs) Baseline up to Week 12 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'.
Trial Locations
- Locations (114)
Teva Investigational Site 54058
🇨🇿Praha, Czechia
Teva Investigational Site 35090
🇫🇷Nantes, France
Teva Investigational Site 35091
🇫🇷Perpignan, France
Teva Investigational Site 54065
🇨🇿Plzen, Czechia
Teva Investigational Site 35089
🇫🇷La Bouexiere, France
Teva Investigational Site 39020
🇩🇰Copenhagen NV, Denmark
Teva Investigational Site 32256
🇩🇪Berlin, Germany
Teva Investigational Site 54056
🇨🇿Brno, Czechia
Teva Investigational Site 54067
🇨🇿Praha, Czechia
Teva Investigational Site 54068
🇨🇿Neratovice, Czechia
Teva Investigational Site 32255
🇩🇪Berlin, Germany
Teva Investigational Site 35092
🇫🇷Murs Erigne, France
Teva Investigational Site 54064
🇨🇿Rokycany, Czechia
Teva Investigational Site 32258
🇩🇪Offenbach, Germany
Teva Investigational Site 51068
🇭🇺Komarom, Hungary
Teva Investigational Site 32243
🇩🇪Berlin, Germany
Teva Investigational Site 32244
🇩🇪Berlin-Neukolln, Germany
Teva Investigational Site 32240
🇩🇪Neu-Isenburg, Germany
Teva Investigational Site 54061
🇨🇿Hradec Kralove, Czechia
Teva Investigational Site 54063
🇨🇿Ostrava - Marianske Hory, Czechia
Teva Investigational Site 54059
🇨🇿Strakonice, Czechia
Teva Investigational Site 32253
🇩🇪Frankfurt/Main, Germany
Teva Investigational Site 32246
🇩🇪Leipzig, Germany
Teva Investigational Site 40003
🇫🇮Turku, Finland
Teva Investigational Site 35093
🇫🇷Lyon Cedex 04, France
Teva Investigational Site 32241
🇩🇪Rudersdorf, Germany
Teva Investigational Site 32251
🇩🇪Frankfurt am Main, Germany
Teva Investigational Site 32257
🇩🇪Berlin, Germany
Teva Investigational Site 51072
🇭🇺Budapest, Hungary
Teva Investigational Site 30055
🇮🇹Cisanello Pisa, Italy
Teva Investigational Site 42011
🇸🇪Lund, Sweden
Teva Investigational Site 31061
🇪🇸Vitoria, Spain
Teva Investigational Site 32249
🇩🇪Hamburg, Germany
Teva Investigational Site 31054
🇪🇸Badalona, Spain
Teva Investigational Site 31055
🇪🇸Sevilla, Spain
Teva Investigational Site 51065
🇭🇺Deszk, Hungary
Teva Investigational Site 34028
🇬🇧London, United Kingdom
Teva Investigational Site 32250
🇩🇪Reinfeld, Germany
Teva Investigational Site 34027
🇬🇧East Sussex, United Kingdom
Teva Investigational Site 31056
🇪🇸Pamplona, Spain
Teva Investigational Site 34024
🇬🇧Chesterfield, United Kingdom
Teva Investigational Site 50179
🇷🇺Kazan, Russian Federation
Teva Investigational Site 42014
🇸🇪Goteborg, Sweden
Teva Investigational Site 42012
🇸🇪Stockholm, Sweden
Teva Investigational Site 31058
🇪🇸Madrid, Spain
Teva Investigational Site 31052
🇪🇸Barcelona, Spain
Teva Investigational Site 53113
🇵🇱Zabrze, Poland
Teva Investigational Site 50174
🇷🇺Yaroslavl, Russian Federation
Teva Investigational Site 31051
🇪🇸Alcorcon, Spain
Teva Investigational Site 37029
🇧🇪Gozee, Belgium
Teva Investigational Site 35088
🇫🇷Brest Cedex 2, France
Teva Investigational Site 51067
🇭🇺Budapest, Hungary
Teva Investigational Site 51077
🇭🇺Csorna, Hungary
Teva Investigational Site 51071
🇭🇺Kaposvar, Hungary
Teva Investigational Site 38048
🇳🇱Alkmaar, Netherlands
Teva Investigational Site 31057
🇪🇸Barcelona, Spain
Teva Investigational Site 31053
🇪🇸Bilbao, Spain
Teva Investigational Site 39021
🇩🇰Odense, Denmark
Teva Investigational Site 40002
🇫🇮Pori, Finland
Teva Investigational Site 33018
🇦🇹Wels, Austria
Teva Investigational Site 33019
🇦🇹Linz, Austria
Teva Investigational Site 37031
🇧🇪Halen, Belgium
Teva Investigational Site 40004
🇫🇮Helsinki, Finland
Teva Investigational Site 51075
🇭🇺Balassagyarmat, Hungary
Teva Investigational Site 80039
🇮🇱Petach Tikva, Israel
Teva Investigational Site 80037
🇮🇱Ramat Gan, Israel
Teva Investigational Site 33020
🇦🇹Grieskirchen, Austria
Teva Investigational Site 40001
🇫🇮Tampere, Finland
Teva Investigational Site 51074
🇭🇺Torokbalint, Hungary
Teva Investigational Site 80041
🇮🇱Zerifin, Israel
Teva Investigational Site 53117
🇵🇱Gdansk, Poland
Teva Investigational Site 53109
🇵🇱Krakow, Poland
Teva Investigational Site 53116
🇵🇱Poznan, Poland
Teva Investigational Site 53115
🇵🇱Wroclaw, Poland
Teva Investigational Site 53101
🇵🇱Zgierz, Poland
Teva Investigational Site 50178
🇷🇺St. Petersburg, Russian Federation
Teva Investigational Site 50177
🇷🇺Moscow, Russian Federation
Teva Investigational Site 37030
🇧🇪Jambes, Belgium
Teva Investigational Site 40005
🇫🇮Jyvaskyla, Finland
Teva Investigational Site 80035
🇮🇱Haifa, Israel
Teva Investigational Site 38049
🇳🇱Leeuwarden, Netherlands
Teva Investigational Site 53103
🇵🇱Strzelce Opolskie, Poland
Teva Investigational Site 50171
🇷🇺Saint Petersburg, Russian Federation
Teva Investigational Site 51073
🇭🇺Kaposvar, Hungary
Teva Investigational Site 51070
🇭🇺Mosdos, Hungary
Teva Investigational Site 51076
🇭🇺Tatabanya, Hungary
Teva Investigational Site 80036
🇮🇱Afula, Israel
Teva Investigational Site 80040
🇮🇱Kfar Saba, Israel
Teva Investigational Site 53110
🇵🇱Bialystok, Poland
Teva Investigational Site 53106
🇵🇱Gdansk, Poland
Teva Investigational Site 53107
🇵🇱Lodz, Poland
Teva Investigational Site 53119
🇵🇱Sopot, Poland
Teva Investigational Site 80038
🇮🇱Rehovot, Israel
Teva Investigational Site 53111
🇵🇱Krakow, Poland
Teva Investigational Site 53100
🇵🇱Krakow, Poland
Teva Investigational Site 53114
🇵🇱Bialystok, Poland
Teva Investigational Site 53102
🇵🇱Lublin, Poland
Teva Investigational Site 50175
🇷🇺Saint-Petersburg, Russian Federation
Teva Investigational Site 53104
🇵🇱Szczecin, Poland
Teva Investigational Site 53105
🇵🇱Tarnow, Poland
Teva Investigational Site 53099
🇵🇱Wroclaw, Poland
Teva Investigational Site 50172
🇷🇺Saratov, Russian Federation
Teva Investigational Site 50173
🇷🇺Tomsk, Russian Federation
Teva Investigational Site 53120
🇵🇱Wroclaw, Poland
Teva Investigational Site 50170
🇷🇺Vsevolozhsk, Russian Federation
Teva Investigational Site 30056
🇮🇹Milano, Italy
Teva Investigational Site 30054
🇮🇹Padova, Italy
Teva Investigational Site 34026
🇬🇧Coventry, United Kingdom
Teva Investigational Site 34022
🇬🇧Dundee, United Kingdom
Teva Investigational Site 34029
🇬🇧Lancashire, United Kingdom
Teva Investigational Site 32259
🇩🇪Grosshansdorf, Germany
Teva Investigational Site 32252
🇩🇪Cottbus, Germany
Teva Investigational Site 32254
🇩🇪Gelsenkirchen, Germany
Teva Investigational Site 32247
🇩🇪Weinheim, Germany