NCT01010178

Brief Summary

Critical combination of various approved drugs in management for patients suffering with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

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

Timeline
Completed

Started Feb 2008

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

Study Start

First participant enrolled

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

1.2 years

First QC Date

November 6, 2009

Last Update Submit

November 6, 2009

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDMacrolidreversibilityTheophyllineCorticosteroidssymptoms PFT

Outcome Measures

Primary Outcomes (1)

  • 15% increasing in forced expiratory volume in 1 second

    6 months

Study Arms (1)

Macrolid, Theophylline, Corticosteroids

EXPERIMENTAL

Approved drug in this setting

Drug: Macrolid, Theophylline, Inhaler Corticosteroids

Interventions

Macrolid, Theophylline, Inhaler CorticosteroidsDRUG

we have no permission to include them in detail because of privacy policy of mentioned journal for publication

Macrolid, Theophylline, Corticosteroids

Eligibility Criteria

Age22 Years - 86 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current or past smoker COPD

You may not qualify if:

  • history of significant occupational or other environmental exposures or a connective tissue disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center of Chemical Injuries, Baqiyatallah Medical Sciences University, Mollasadra St,

Tehran, 19945-546, Iran

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Theophylline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

February 1, 2008

Primary Completion

April 1, 2009

Study Completion

July 1, 2009

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

IR(1)