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OpenTrials
Completed

NCT Number: NCT00642161

New Version Pulmicort Turbuhaler USA Children

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

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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

6 year–17 year

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 females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
  • A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
  • Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.

Exclusion criteria

  • Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
  • Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
  • Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.

Treatment and study plan

Budesonide

Drug

Other names: Pulmicort

Primary outcomes

  1. Change from Baseline in % predicted Forced Expiratory Volume in 1 second

    Time frame: Week 2, 4 and 8, then at week 12

Secondary outcomes

  1. Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate

    Time frame: Week 2, 4 and 8, then at week 12

  2. Incidence of Adverse Events

    Time frame: Week 2, 4 and 8, then at week 12

  3. Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration

    Time frame: 6 or 12 hours post dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.

Important dates

Study start
2002
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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