Study Comparing Dual Combination of Product (Budesonide and Formoterol) Given Via Two Different Inhalers. To See Which One Results in the Best Effect on Breathing.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2020-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Study comparing the same drugs as a dual combination product (budesonide and formoterol) given via two different inhalers. To see which one results in the best effect on breathing.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Symbicort® Turbuhaler® (Budesonide/Formoterol) in Chronic Obstructive Pulmonary Disease (COPD)

NCT00837629

Chronic Obstructive Pulmonary Disease

COMPLETED

A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD

NCT00206167

Chronic Obstructive Pulmonary Disease

COMPLETED PHASE3

Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease

NCT02157935

COPD Patients

COMPLETED PHASE3

A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

NCT03836677

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE3

To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product

NCT02308098

Asthma

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate Inhalation Aerosol Administered with a Spacer Compared with Symbicort® Turbuhaler® in Subjects with Severe to Very Severe Chronic Obstructive Pulmonary Disease and Low Peak Inspiratory Flow to assess lung function

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Budesonide and formoterol fumarate (MDI BFF)

Subject treated with MDI BFF followed by washout period

Group Type EXPERIMENTAL

BFF

Intervention Type COMBINATION_PRODUCT

Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)

Symbicort Turbuhaler

Subject treated with Symbicort followed by washout period

Group Type ACTIVE_COMPARATOR

Symbicort Turbuhaler

Intervention Type COMBINATION_PRODUCT

Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BFF

Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)

Intervention Type COMBINATION_PRODUCT

Symbicort Turbuhaler

Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Subject must be 40 to 80 years of age inclusive, at the time of signing the ICF.
2. Individuals who have a physician diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
3. Require COPD maintenance therapy: all subjects must be receiving 2 or more inhaled maintenance therapies, including at least 1 long-acting bronchodilator, for the management of their COPD for at least 4 weeks prior to Visit 1.
4. A post-bronchodilator FEV1/FVC of \<0.70 and post-bronchodilator FEV1 of \<50% predicted normal value at Visit 2.
5. A pre-bronchodilator PIF of \<50 L/min using the InCheck Inspiratory Flow Measurement Device set to Turbuhaler S resistance at Visit 2.
6. Current or former smokers with history of at least 10 pack-years of cigarette smoking.

Exclusion Criteria

1. Current diagnosis of asthma, in the opinion of the Investigator.
2. Other respiratory disorders including known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), immune deficiency disorders, severe neurological disorders affecting control of the upper airway, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease.
3. A moderate or severe exacerbation of COPD ending within 6 weeks prior to randomization (Visit 3).
4. Need for mechanical ventilation within 3 months prior to Visit 1.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No