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Completed

NCT Number: NCT00667992

Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma

This study is being carried out to see if budesonide with HFA is effective, safe and well tolerated compared with budesonide CFC. Budesonide HFA has been already given in other research studies, in both healthy volunteers and subjects with asthma.

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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–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Dundee, Scotland, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients suffering from stable, persistent, mild to moderate asthma as defined by Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %
  • ICS taking ≤ 1000 μg BDP per day, or equivalent
  • Methacholine PC20 < 4 mg/mL

Exclusion criteria

  • Known or suspected hypersensitivity to budesonide or any other constituents of the budesonide HFA pMDI or budesonide CFC pMDI.
  • Currently a smoker or who has ceased smoking within 6 months of Visit 1.
  • Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis

Treatment and study plan

Budesonide HFA

Drug

standard daily inhaled dose

Budesonide CFC

Drug

standard daily inhaled dose

Primary outcomes

  1. PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)

    Time frame: Baseline and week 2

    Provocative concentration of methacholine is that causing a 20% fall in FEV1. The methacholine challenge test entailed the patient inhaling from an aerosol containing doubling concentrations of methacholine over a period of 2 minutes until FEV1 had been reduced by 20%.

    The ratio of Methacholine concentration measured at 2 weeks to that at Baseline.

Secondary outcomes

  1. Peak Exploratory Flow (PEF)

    Time frame: Baseline to week 2 recorded daily

    Change in PEF at Week 2 from baseline, mean over all days in run-in and all dasy in treatment period, with baseline as covariate.

  2. FEV1 (Forced Expiratory Volume in 1 Second)

    Time frame: Baseline to week 2

    FEV1 change from baseline

  3. FEF 25-75 (Forced Expiratory Flow 25-75)

    Time frame: Baseline and week 2

    FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline

  4. eNO (Exhaled Nitrogen Oxide)

    Time frame: baseline and week 2

    eNO ratio of baseline

  5. Asthma Symptom Score Morning

    Time frame: 2 weeks

    Asthma Symptom score recorded daily in the morning: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the morning is presented.

  6. Asthma Symptom Score Evening

    Time frame: 2 weeks

    Asthma Symptom score recorded daily in the evening: Scale: 0-3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily in the evening is presented.

  7. Asthma Symptom Score Total

    Time frame: 2 weeks

    Asthma Symptom score recoded daily, Total. Scale: 0 - 3. 0 = None; no asthma symptoms. 1 = Mild symptoms; aware of asthma symptoms but easily tolerated. 2 = Moderate symptoms; asthma causing enough discomfort to cause problems with normal activities (or with sleep). 3 =Severe symptoms; unable to do normal activities. The average of means for values recorded daily is presented.

  8. Rescue Medication Morning

    Time frame: 2 weeks

    The average of means for inhalations of rescue medication in the morning is presented.

  9. Rescue Medication Evening

    Time frame: 2 weeks

    The average of means for inhalations of rescue medication in the evening is presented.

  10. Rescue Medication Total

    Time frame: 2 weeks

    The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.

  11. Peak Exploratory Flow (PEF) Morning

    Time frame: 2 weeks

    Peak Exploratory Flow (PEF) recorded daily in the morning

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 3, Randomised, Open-label, Crossover Study to Compare HFA vs CFC pMDI Formulations of Budesonide on Methacholine Hyper-reactivity in Patients With Stable, Persistent, Mild to Moderate Asthma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 28, 2008
Registry last updated
Nov 7, 2012

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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