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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660114
First Posted: April 17, 2008
Last Update Posted: May 28, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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: Time Perspective: 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:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patient Symptom Score [ Time Frame: 7 weeks (plus or minus 3 days ) ]

Secondary Outcome Measures:
  • Patient Compliance Report [ Time Frame: 7 weeks (plus or minus 3 days ) ]
  • Investigator Assessment Report [ Time Frame: 7 weeks (plus or minus 3 days ) ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lars-Göran Carlsson - Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00660114     History of Changes
Other Study ID Numbers: NIS-RCN-PUL-2008/1
First Submitted: April 15, 2008
First Posted: April 17, 2008
Last Update Posted: May 28, 2009
Last Verified: May 2009

Keywords provided by AstraZeneca:
Cough variant asthma
Pulmicort® Respules®
Chinese patient Eligibility

Additional relevant MeSH terms:
Asthma
Cough
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms