Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients - Full Text View

Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients (PUL NIS)

This study has been completed.

First Received: April 15, 2008 Last Updated: May 27, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00660114

Purpose

This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in cough variant asthma in patient aged 5-year old or younger in outpatient department

Condition
Cough Variant Asthma

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Patient Aged 5-Year Old or Younger in Outpatient Department

Resource links provided by NLM:

MedlinePlus related topics: Asthma Cough

Drug Information available for: Budesonide

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Patient Symptom Score [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient Compliance Report [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]
Investigator Assessment Report [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	914
Study Start Date:	April 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient aged 5-year old or younger who has been diagnosed as cough variant asthma and decided by physician to use Pulmicort® Respules® inhalation.

Criteria

Inclusion Criteria:

Provision of informed consent
Patient who has been prescribed Pulmicort® Respules® according to physician's judgement, irrespective of the inclusion in the study.
The usage of Pulmicort® Respules® follows local authorised package insert.

Exclusion Criteria:

Allergy to any ingredient of Pulmicort® Respules®
With history of Leukotriene Modifier (LM) usage prior to 2 weeks of recruitment or following plan.
Have used systemic/inhaled steroid prior to 2 weeks of recruitment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660114

Show 32 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Hong Jianguo, Professor

Shanghai Jiao Tong University Affiliated First People's Hospital,

More Information

No publications provided

Responsible Party:	AstraZeneca ( Lars-Göran Carlsson - Medical Science Director )
Study ID Numbers:	NIS-RCN-PUL-2008/1
Study First Received:	April 15, 2008
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00660114 History of Changes
Health Authority:	China: State Food and Drug Administration

Keywords provided by AstraZeneca:

Cough variant asthma
Pulmicort® Respules®
Chinese patient Eligibility

Study placed in the following topic categories:

Anti-Inflammatory Agents
Bronchial Diseases
Hormone Antagonists
Respiration Disorders
Hormones, Hormone Substitutes, and Hormone Antagonists
Budesonide
Anti-Asthmatic Agents
Asthma
Cough
Hormones
Glucocorticoids

Signs and Symptoms
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Signs and Symptoms, Respiratory
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Signs and Symptoms
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Signs and Symptoms, Respiratory
Immune System Diseases

Respiration Disorders
Budesonide
Cough
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on July 02, 2009