Assess Particle Deposition and Acute Effects of Symbicort® Forte Turbohaler®) in COPD Patients.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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

Computational Fluid Dynamics (CFD) is a new functional imaging method. Since CFD is very sensitive to detect small changes, it might be worthwhile to study the acute effect of formoterol and budesonide combination therapy (Symbicort® forte Turbohaler®) on the upper airway dimensions in severe COPD patients (GOLD III). The increased sensitivity of this technique makes it possible to detect changes in airway caliber in early stages. The regional distribution of resistance and the change in this parameter will provide more insight into the mode of action of the product.

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

Comparison Between Symbicort® and Prednisolone in COPD

NCT00259779

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

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.

NCT04078126

Chronic Obstructive Pulmonary Disease (COPD)

COMPLETED PHASE3

Detailed Description

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

Conditions

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

Chronic Obstructive Pulmonary Disease

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

DOUBLE

Participants Investigators

Study Groups

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

Symbicort® forte Turbohaler®

Group Type OTHER

Symbicort® forte Turbohaler®

Intervention Type DRUG

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Placebo (lactose)

Group Type PLACEBO_COMPARATOR

Symbicort® forte Turbohaler®

Intervention Type DRUG

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Interventions

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

Symbicort® forte Turbohaler®

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

1. Patients with documented COPD based on the following criteria:

Smoking history of at least 10 pack-years and decreased Tiffeneau index (FEV1/(F)VC \< 0.70).
2. Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
3. Male or female patients aged ≥ 40 years.
4. Patients should be treated according to GOLD guidelines before study start.
5. Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
6. Maintained on stable respiratory medications for 6 weeks prior to visit 1.
7. Written informed consent obtained.

Exclusion Criteria

1. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
2. Inability to carry out pulmonary function testing.
3. A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
4. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study
5. A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
6. Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
7. A history of thoracotomy with pulmonary resection.
8. Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
9. History of alcohol or drug abuse.
10. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
11. Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
12. Patients treated with any non-permitted concomitant medication (see 7.2).

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No