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

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ClinicalTrials.gov Identifier: NCT00667992
Recruitment Status : Completed
First Posted : April 28, 2008
Results First Posted : November 7, 2012
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide HFA Drug: Budesonide CFC Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Budesonide Hydrofluoroalkane (HFA) 100
Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
 Drug: Budesonide HFA
standard daily inhaled dose
Active Comparator: Budesonide HFA 400
Budesonide HFA 400 mcg twice daily for 2 weeks
 Drug: Budesonide HFA
standard daily inhaled dose
Active Comparator: Budesonide Chlorofluorocarbon (CFC) 100
Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
 Drug: Budesonide CFC
standard daily inhaled dose
Active Comparator: Budesonide CFC 400
Budesonide CFC 400 mcg twice daily for 2 weeks
 Drug: Budesonide CFC
standard daily inhaled dose


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667992


Locations
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United States, Pennsylvania
Research Site
King of Prussia, Pennsylvania, United States
United Kingdom
Research Site
Dundee, Scotland, United Kingdom
Research Site
Perth, Scotland, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Brian Lipworth, PhD, MD Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00667992    
Other Study ID Numbers: D5252C00008
First Posted: April 28, 2008    Key Record Dates
Results First Posted: November 7, 2012
Last Update Posted: November 7, 2012
Last Verified: October 2012
Keywords provided by AstraZeneca:
Asthma hyperreactivity
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
 Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists