Effects of Symbicort on the Ventilatory Kinematics

NCT01712854 | Terminated Phase 4 Results

• 1 other identifier: AAAI1932
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate how budesonide/formoterol fumarate dihydrate (Symbicort ©) affects dynamic hyperinflation in patients with obstructive disease using Optoelectronic Plethysmography (OEP). This study is unique as it will be the first randomized, doubleblind, crossover study with a placebo inhaler and budesonide/formoterol fumarate dihydrate as the intervention which will evaluate the effects on ventilatory mechanics through the use of OEP. The investigators plan to demonstrate that budesonide/formoterol fumarate dihydrate impacts dynamic hyperinflation which can be detected with OEP, and that budesonide/formoterol fumarate dihydrate may have an effect in the short term on exercise capacity during a constant load exercise test. The changes in ventilatory mechanics measured after budesonide/formoterol fumarate dihydrate by OEP will provide a unique evaluation of budesonide/formoterol fumarate dihydrate in a controlled setting also demonstrating the utility of OEP in evaluating of the effects of a medical treatment on hyperinflation in individuals with chronic obstructive lung disease (COPD).

1. 1.Primary Objective/Hypothesis: Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. The investigators hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.
2. 2.Primary Endpoint: Our primary endpoint is the change in dynamic hyperinflation, specifically end expiratory volumes, dynamic lung volumes and diaphragmatic paradoxical breathing as measured by OEP.
3. 3.Secondary Objective: Our secondary objective is to evaluate duration of steady state exercise and exercise capacity before and after treatment. Our secondary hypothesis is that decreases in dynamic hyperinflation during exercise will lead to improvements in dyspnea with exercise, and allow for increases in exercise capacity.
4. 4.Secondary endpoint: Exercise time, change in Borg scale at rest vs. Borg scale at steady state vs. Borg at end exercise.

Conditions

Chronic Obstructive Lung Disease

Keywords

COPD; Chronic Obstructive Lung Disease; Long acting beta agonist

Outcome Measures

Primary Outcomes (1)

• The Change in Dynamic Hyperinflation Measured by End Expiratory Volumes Recorded by Optoelectronic Plethysmography (OEP).

  Our objective is to measure baseline, post treatment and post exercise spirometry and evaluate exercise dynamic hyperinflation before and after treatment using OEP. We hypothesize that budesonide/formoterol fumarate dihydrate will decrease dynamic hyperinflation as measured by OEP.

  2 hours

Secondary Outcomes (1)

• Exercise Time in Steady State Exercise

  2 hours

Study Arms (2)

Symbicort

EXPERIMENTAL

A combination of budesonide + long acting beta agonist (Symbicort): Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg

Drug: Symbicort

Budesonide only

PLACEBO COMPARATOR

Budesonide 80 mcg (Entocort EC) only

Drug: Budesonide

Interventions

Budesonide DRUG

budesonide 80 mcg

Budesonide only

Symbicort DRUG

A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg

Symbicort

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe COPD by Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
• Approval by pulmonologist
• Informed consent
• Age 40 to 75
• Males and females
• All races
• Ex smoker or non smoker
• Prior therapy allowed

You may not qualify if:

• No active cardiac disease
• Alpha1 Antitrypsin Deficiency
• Active smoking
• Reactive Airways Disease
• Pulmonary Hypertension
• Comorbid conditions preventing exercise (arthritic, neurologic, vascular, or other conditions)
• BMI\>30
• Current enrollment in any other concurrent study at Columbia University Medical Center or sponsored by AstraZeneca at any other sites
• Participation in any pharmacologic studies in the last 6 months prior to enrollment in this study

Sponsors & Collaborators

• Columbia University: lead
• AstraZeneca: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: CU PRS Administrator
• Organization: Columbia University

crchelp@columbia.edu

212-342-1643

Study Officials

• Matthew Bartels, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2012
• First Posted: October 24, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 2, 2016
• Results First Posted: April 22, 2016

Record last verified: 2016-07

Locations

US (1)