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

NCT01329276 | Completed Phase 4 DMC

• 2 other identifiers: PML_DOC_0905_/_ISSSYMB00202009-016502-16
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Symbicort; Turbohaler; Computational Fluid Dynamics; Functional Imaging; Budesonide; Formoterol

Outcome Measures

Primary Outcomes (2)

• total airway resistance

  To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.

• total airway volume

  To evaluate the effect of the combination therapy on the upper airway dimensions and to assess the particle deposition with Computational Fluid Dynamics (CFD). The parameters that will be obtained with CFD and used as primary outcome variables are total airway resistance and total airway volume.

Secondary Outcomes (1)

• effect of formoterol and budesonide combination therapy on lung function

Study Arms (2)

Symbicort® forte Turbohaler®

OTHER

Drug: Symbicort® forte Turbohaler®

Placebo (lactose)

PLACEBO COMPARATOR

Drug: Symbicort® forte Turbohaler®

Interventions

Symbicort® forte Turbohaler® DRUG

320 µg budesonide / 9 µg formoterol fumarate dihydrate

Placebo (lactose); Symbicort® forte Turbohaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients should present severe COPD with an FEV1 between 50 and 30% of predicted (GOLD 3).
• Male or female patients aged ≥ 40 years.
• Patients should be treated according to GOLD guidelines before study start.
• Patients with, in the opinion of the investigator, a co-operative attitude and ability to be trained to correctly use the TurbohalerR.
• Maintained on stable respiratory medications for 6 weeks prior to visit 1.
• Written informed consent obtained.

You may not qualify if:

• Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
• Inability to carry out pulmonary function testing.
• A respiratory infection or exacerbation of COPD in the four weeks prior to screening.
• 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
• A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease.
• Cancer or any other chronic disease with poor prognosis and/or affecting patient status.
• A history of thoracotomy with pulmonary resection.
• Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients.
• History of alcohol or drug abuse.
• Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study.
• Patients who received any investigational new drug within the last 4 weeks prior to the screening visit.
• Patients treated with any non-permitted concomitant medication (see 7.2).

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• AstraZeneca: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem (Antwerp), Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wilfried A De Backer, MD PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 5, 2011
• Study Start: June 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: April 5, 2011

Record last verified: 2011-03

Locations

BE (1)