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OpenTrials
Completed

NCT Number: NCT00642187

New Version Pulmicort Turbuhaler USA Adults

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. 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

18 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

  • Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
  • To enter the run in period, subjects were also required to have the following:
  • A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
  • At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

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 (28 days) 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 the study. Subject must not smoke or have smoked within 6 months of the study.

Treatment and study plan

Budesonide

Drug

Other names: Pulmicort

Placebo

Drug

Primary outcomes

  1. Change from Baseline in 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 and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.

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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