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OpenTrials
Completed

NCT Number: NCT00642122

Adults With Moderate to Severe Asthma

A study to compare the safety and effectiveness of 5 different ways of taking Pulmicort when given to asthma patients aged 12 years and above.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female aged 12 or over who have asthma
  • Ability to properly use an electronic diary
  • Able and willing to nebulize for up to 20 minutes every morning and evening

Exclusion criteria

  • Hospitalised at least one once or required emergency treatment due to asthma in the previous 6 months
  • Planned hospitalisation during the study
  • pregnant women or women planning to become pregnant

Treatment and study plan

Budesonide

Drug

0.5mg once daily

Other names: Pulmicort RESPULES

Primary outcomes

  1. Forced Expiratory Volume in 1 second in patients allocated treatment with Pulmicort REPSULES at 0.5mg and 2.0mg.

    Time frame: Day -14, 1, and every 28 days thereafter

Secondary outcomes

  1. Percentage of symptom free days

    Time frame: Day -14, 1, and every 28 days thereafter

  2. Percentage of symptom free nights

    Time frame: Day -14, 1, and every 28 days thereafter

  3. Percentage of symptom free 24-hours

    Time frame: Day -14, 1, and every 28 days thereafter

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomized, Blinded, Multicenter, Parallel Study Comparing the Efficacy and Safety of Pulmicort Respules at 0.5mg QD, 1.0mg QD, 1.0mg Bid, 2.0mg Bid and Pulmicort Turbuhaler at 4.00mcg Bid on Adolescents (12 Yrs of Age and Older) With Adults With Moderate to Severe Asthma.

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Mar 24, 2008
Registry last updated
Jan 24, 2011

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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