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

October 9, 2012 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Scotland
      • Dundee, Scotland, United Kingdom
        • Research Site
      • Perth, Scotland, United Kingdom
        • Research Site
  • United States
    • Pennsylvania
      • King of Prussia, Pennsylvania, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to week 2 recorded daily
FEV1 (Forced Expiratory Volume in 1 Second)
Time Frame: Baseline to week 2
FEV1 change from baseline
Baseline to week 2
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
Baseline and week 2
eNO (Exhaled Nitrogen Oxide)
Time Frame: baseline and week 2
eNO ratio of baseline
baseline and week 2
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.
2 weeks
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.
2 weeks
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.
2 weeks
Rescue Medication Morning
Time Frame: 2 weeks
The average of means for inhalations of rescue medication in the morning is presented.
2 weeks
Rescue Medication Evening
Time Frame: 2 weeks
The average of means for inhalations of rescue medication in the evening is presented.
2 weeks
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.
2 weeks
Peak Exploratory Flow (PEF) Morning
Time Frame: 2 weeks
Peak Exploratory Flow (PEF) recorded daily in the morning
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Brian Lipworth, PhD, MD, Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 27, 2008

First Posted (ESTIMATE)

April 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 7, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5252C00008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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