NCT00974805

Brief Summary

This study is investigating the possible mechanisms of action of an inhaled treatment (Seretide), currently used worldwide in millions of patients with COPD (Chronic Obstructive Pulmonary Disease) and how it improves the symptoms of these patients. Previous research has failed to identify the mechanisms at play other than dilation of the airways. The research community has long thought the mechanism to be immune based or anti inflammatory but despite intensive research this has not yet been identified.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

September 8, 2009

Last Update Submit

December 5, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDEmphysemaBronchitis

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measures are change in cell type and activation status

    56 days

Secondary Outcomes (1)

  • Change in sputum and serum cytokines Change in bacterial colonization

    56 days

Study Arms (1)

Seretide 500 Accuhaler

EXPERIMENTAL

Seretide 500 Accuhaler one inhalation BD

Drug: Seretide 500 Accuhaler

Interventions

Seretide 500 AccuhalerDRUG

Seretide 500 accuhaler one inhalation BD

Seretide 500 Accuhaler

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>35yrs.
  • \>10 Pack Years COPD as defined as an FEV1\<70% and an FEV1/FVC ratio of \<70%

You may not qualify if:

  • Asthma
  • Lung cancer
  • Bronchiectasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveEmphysemaBronchitis

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsBronchial Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2009

First Posted

September 10, 2009

Study Start

February 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

GB(1)