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Airway Clearance Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Budesonide/Formoterol Turbuhaler

Salmeterol/Fluticasone Diskus

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 >80% of PN, Non-smoker

Exclusion Criteria:

COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,

Sites / Locations

Research Site
Research Site

Outcomes

Primary Outcome Measures

Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers

Secondary Outcome Measures

Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients

Correlation between baseline lung function and AUC of steroids after inhalation.

Full Information

NCT ID

NCT00379028

First Posted

September 20, 2006

Last Updated

January 21, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00379028

Brief Title

Airway Clearance Study

Official Title

A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Budesonide/Formoterol Turbuhaler

Other Intervention Name(s)

Symbicort

Intervention Type

Drug

Intervention Name(s)

Salmeterol/Fluticasone Diskus

Primary Outcome Measure Information:

Title

Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers

Secondary Outcome Measure Information:

Title

Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients

Title

Correlation between baseline lung function and AUC of steroids after inhalation.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration. Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 >80% of PN, Non-smoker Exclusion Criteria: COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder, Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christer Hultquist, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tim Harrisson, MD

Organizational Affiliation

Nottingham University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Lund

Country

Sweden

Facility Name

Research Site

City

Nottingham

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

19878590

Citation

Dalby C, Polanowski T, Larsson T, Borgstrom L, Edsbacker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009 Oct 31;10(1):104. doi: 10.1186/1465-9921-10-104.

Results Reference

derived

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Airway Clearance Study

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