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Real Life Effectiveness in Patients With Not Optimally Controlled Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shih-Lung Cheng, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01647646
First received: July 19, 2012
Last updated: July 23, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Seretide
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Real Life Effectiveness in Patients With Not Optimally Controlled Asthma: Symbicort SMART, or Other ICS/LABA With as Needed SABA

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • the percentage of asthma total and well control [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    F/U clinical asthma control status and percentage of Acute exacerbation


Secondary Outcome Measures:
  • percentage of asthma acute exacerbation [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Enrollment: 200
Study Start Date: March 2009
Study Completion Date: March 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Symbicort

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
Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
Other Name: Symbicort compared with Seretide
Experimental: Seretide
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
Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
Other Name: Symbicort compared with Seretide

Detailed Description:
  1. All not-well controlled asthma patients would include the study.
  2. We will compare three ways of asthma control including SMART, fixed doses with regular doses and fixed doses with higher doses
  3. We will evaluate the efficacy/safety for these not-well controlled patients.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • asthma not well control

Exclusion Criteria:

  • COPD
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shih-Lung Cheng, Chief, Division of Pulmonary Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01647646     History of Changes
Other Study ID Numbers: 97083
Study First Received: July 19, 2012
Last Updated: July 23, 2012
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by Far Eastern Memorial Hospital:
asthma
SMART
fixed dose

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Fluticasone, salmeterol drug combination
 Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013