NCT01647646

Brief Summary

In real life, the investigators will be using different strategies including SMART therapy or other ICS/LABA (medium and high dose) therapy and measure the efficacy for asthma control.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 asthma

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

March 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2012

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

July 19, 2012

Last Update Submit

July 23, 2012

Conditions

Asthma

Keywords

asthmaSMARTfixed dose

Outcome Measures

Primary Outcomes (1)

  • the percentage of asthma total and well control

    F/U clinical asthma control status and percentage of Acute exacerbation

    one year

Secondary Outcomes (1)

  • percentage of asthma acute exacerbation

    one year

Study Arms (2)

Symbicort

ACTIVE COMPARATOR

We will evaluate the efficacy fot Symbicort use. The usage was 2 doses bid for one year period. Intervention drug: Seretide fixed doses therapy

Drug: Seretide

Seretide

EXPERIMENTAL

In non-well asthma controlled patients, experimental study with Seretide regular doses (125 2 doses bid for one year) and higher doses (250 2 doses bid) for one year

Drug: Seretide

Interventions

SeretideDRUG

Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety

Also known as: Symbicort compared with Seretide
SeretideSymbicort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asthma not well control

You may not qualify if:

  • COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Salmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pulmonary Medicine

Study Record Dates

First Submitted

July 19, 2012

First Posted

July 23, 2012

Study Start

March 1, 2009

Primary Completion

February 1, 2011

Study Completion

March 1, 2012

Last Updated

July 24, 2012

Record last verified: 2012-07