Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01676987

Acronym

Ach-ALN

Enrollment

181

Registered

2012-08-31

Start date

2009-04-30

Completion date

2011-06-30

Last updated

2012-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Budesonide, Adrenergic beta-2 receptor agonists.

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.

Detailed description

the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day. The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.

Interventions

DRUGFixed combination of budesonide and formoterol

Delivered dry powder inhaler for 12 weeks.

DRUGBudesonide

Delivered dry powder inhaler for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 77 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of uncontrolled asthma * Age ranged from 18 to 77 years * Nonsmokers

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
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	12 weeks	the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026