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NCT Number: NCT02143739

The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China

The primary objective of the NIS is to evaluate the severity of newly diagnosed asthma patients based on Global Initiative for Asthma (GINA) severity category (GINA 2006 update).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Baotou, China

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About this study

This is a multi-centre, prospective non-interventional study planned to be conducted in China. The study aims to recruit about 5000 newly diagnosed patients from about 50 tier 3 hospitals with respiratory department. Each site recruits about 50-150 patients.

The primary variable will be distribution of severity based on GINA definition (GINA 2006 update) at baseline in the total population.

There will be 4 visits for this study, Informed consent and following study procedures (ACQ-5(asthma control questionnaire), severity assessment) will be done at visit 1. After that, according to clinical practice in China patients usually go to the clinic every 4 weeks. Asthma control status, ACQ-5 and sever exacerbation will be assessed at each clinic visit till 12 weeks (visit 2, 3, 4).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newly diagnosed asthma patients who are not on inhaled gluococorticosteroid within 3 months.
  • Out-patient with an age of 18 years and above
  • Signed and dated informed consent The prescription of the medicinal product is clearly separated from the decision to include the subject in the NIS. Generally, asthma medication refers to those recommended in GINA guideline (GINA2012 update) and decided by investigator.

Exclusion criteria

  • Participating in any clinical trial during the last 90 days
  • Have COPD
  • With asthma exacerbation

Treatment and study plan

Primary outcomes

  1. Asthma Severity assessment based on GINA definition (GINA 2006 update) at baseline in the total population

    Time frame: Day 1

    severity based on GINA definition (GINA 2006 update) at baseline in the total population.

Secondary outcomes

  1. evaluate the control level of initial 12 weeks treatment based on Assessment of Current Clinical Control in GINA (GINA 2012 update).

    Time frame: up to 3 months

    The asthma control status assessment will be based on Assessment of Current Clinical Control in GINA (GINA 2012 update).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

The Severity of Newly Diagnosed Asthma Patients and the Result of Initial 12 Weeks Treatment in China.

Acronym: INITIAL

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 21, 2014
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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