Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
Ach-ALN
1 other identifier
interventional
181
0 countries
N/A
Brief Summary
To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 asthma
Started Apr 2009
Typical duration for phase_3 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedAugust 31, 2012
August 1, 2012
1.4 years
August 29, 2012
August 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma
the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
12 weeks
Study Arms (2)
Fixed Combination of Budesonide and formoterol
EXPERIMENTALGroup 1 (experimental): Fixed Combination of Budesonide and formoterol
Budesonide
ACTIVE COMPARATORGroup 2 (comparator): Budesonide
Interventions
Delivered dry powder inhaler for 12 weeks.
Delivered dry powder inhaler for 12 weeks.
Eligibility Criteria
You may qualify if:
- Diagnosis of uncontrolled asthma
- Age ranged from 18 to 77 years
- Nonsmokers
You may not qualify if:
- Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization
- Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3
- Diabetes mellitus
- Pregnancy
- Neuropsychiatric diseases
- Pulmonary malformations, tuberculosis, Cystic fibrosis
- Immunosuppressive treatment
- Hospitalization for asthma or respiratory infection in last 30 days
- Severe systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. Evaluation of the efficacy and safety of a fixed-dose, single-capsule budesonide-formoterol combination in uncontrolled asthma: a randomized, double-blind, multicenter, controlled clinical trial. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. doi: 10.1590/s1806-37132012000400004. English, Portuguese.
PMID: 22964926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emílio Pizzichini
NUPAIVA Asthma Research Center, UFSC- Brazil
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
April 1, 2009
Primary Completion
September 1, 2010
Study Completion
June 1, 2011
Last Updated
August 31, 2012
Record last verified: 2012-08