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

A Randomized, Double-blind, Placebo-controlled, Two Way Cross-over Study to Assess the Particle Deposition and Acute Effects of Formoterol and Budesonide Combination Therapy (Symbicort® Forte Turbohaler®) on the Upper Airway Dimensions in COPD Patients.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Symbicort® forte Turbohaler®

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem (Antwerp), Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Symbicort® forte Turbohaler®	Drug: Symbicort® forte Turbohaler®; 320 µg budesonide / 9 µg formoterol fumarate dihydrate
Placebo Comparator: Placebo (lactose)	Drug: Symbicort® forte Turbohaler®; 320 µg budesonide / 9 µg formoterol fumarate dihydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description
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 Outcome Measures

Outcome Measure	Measure Description
effect of formoterol and budesonide combination therapy on lung function	The secondary objective of this study is to assess the effect of formoterol and budesonide combination therapy on lung function (spirometry, body plethysmography and resistance).

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Wilfried A De Backer, MD PhD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: March 30, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): April 5, 2011
• Last Update Submitted That Met QC Criteria: April 1, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: COPD; Symbicort; Formoterol; Budesonide; Functional Imaging; Computational Fluid Dynamics; Turbohaler
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: PML_DOC_0905_/_ISSSYMB0020; 2009-016502-16 (EudraCT Number)