AsthmaPhase 3NCT00667992

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

A Phase 3 study testing Budesonide HFA and Budesonide CFC in people with Asthma, run by AstraZeneca at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Budesonide HFA and Budesonide CFC
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 99 participants
Where: 3 sitesin 2 countries
Study dates: Apr 2008to May 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United Kingdom2 sites

Research Site
Dundee, Scotland
Research Site
Perth, Scotland

Other trials in United Kingdom

United States1 site

Research Site
King of Prussia, Pennsylvania

Other trials in United States

About this study

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

Conditions: Asthma
Being tested: Budesonide HFA, Budesonide CFC
Keywords: Asthma hyperreactivity
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Budesonide HFADrug
standard daily inhaled dose
Budesonide CFCDrug
standard daily inhaled dose

Study groups in NCT00667992
Study group	Role	What they receive
Budesonide Hydrofluoroalkane (HFA) 100	Active comparator	Budesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks Receives: Drug: Budesonide HFA
Budesonide HFA 400	Active comparator	Budesonide HFA 400 mcg twice daily for 2 weeks Receives: Drug: Budesonide HFA
Budesonide Chlorofluorocarbon (CFC) 100	Active comparator	Budesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks Receives: Drug: Budesonide CFC
Budesonide CFC 400	Active comparator	Budesonide CFC 400 mcg twice daily for 2 weeks Receives: Drug: Budesonide CFC

What is being measured

The primary outcome is the main question the study is designed to answer.

PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)
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.
Measured: Baseline and week 2

Secondary outcomes (11)

Peak Exploratory Flow (PEF)
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.
Measured: Baseline to week 2 recorded daily
FEV1 (Forced Expiratory Volume in 1 Second)
FEV1 change from baseline
Measured: Baseline to week 2
FEF 25-75 (Forced Expiratory Flow 25-75)
FEF 25-75- Forced expiratory flow over the middle one half of the FVC. The results are expressed as the change from baseline
Measured: Baseline and week 2
eNO (Exhaled Nitrogen Oxide)
eNO ratio of baseline
Measured: baseline and week 2
Asthma Symptom Score Morning
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.
Measured: 2 weeks
Asthma Symptom Score Evening
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.
Measured: 2 weeks
Asthma Symptom Score Total
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.
Measured: 2 weeks
Rescue Medication Morning
The average of means for inhalations of rescue medication in the morning is presented.
Measured: 2 weeks
Rescue Medication Evening
The average of means for inhalations of rescue medication in the evening is presented.
Measured: 2 weeks
Rescue Medication Total
The average of means for inhalations of rescue medication in morning and evening combined over a 24 hour period is presented.
Measured: 2 weeks
Peak Exploratory Flow (PEF) Morning
Peak Exploratory Flow (PEF) recorded daily in the morning
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008May 2009

First posted28 Apr 2008 (estimated)
Study startApr 2008
Primary completionMay 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00667992
Sponsor's protocol ID: D5252C00008
Status last verified: Oct 2012
First submitted: 23 Apr 2008
Last updated: 7 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.
PubMed 28065396

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00667992
Acronym / sponsor ID: D5252C00008
Conditions: Asthma
Keywords: Asthma hyperreactivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: May 2009 (actual)
Study completion: May 2009 (actual)
First posted: 28 Apr 2008 (estimated)
Results: Posted 7 Nov 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Budesonide Hydrofluoroalkane (HFA) 100	Active comparator	Drug: Budesonide HFABudesonide Hydrofluoroalkane (HFA) 100 mcg twice daily for 2 weeks
Budesonide HFA 400	Active comparator	Drug: Budesonide HFABudesonide HFA 400 mcg twice daily for 2 weeks
Budesonide Chlorofluorocarbon (CFC) 100	Active comparator	Drug: Budesonide CFCBudesonide Chlorofluorocarbon(CFC) 100 mcg twice daily for 2 weeks
Budesonide CFC 400	Active comparator	Drug: Budesonide CFCBudesonide CFC 400 mcg twice daily for 2 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Budesonide HFAstandard daily inhaled dose	Drug	Budesonide HFA 400, Budesonide Hydrofluoroalkane (HFA) 100
Budesonide CFCstandard daily inhaled dose	Drug	Budesonide CFC 400, Budesonide Chlorofluorocarbon (CFC) 100

Primary outcome

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.

11 secondary outcomes

Peak Exploratory Flow (PEF)
Time frame: Baseline to week 2 recorded daily
FEV1 (Forced Expiratory Volume in 1 Second)
Time frame: Baseline to week 2
FEF 25-75 (Forced Expiratory Flow 25-75)
Time frame: Baseline and week 2
eNO (Exhaled Nitrogen Oxide)
Time frame: baseline and week 2
Asthma Symptom Score Morning
Time frame: 2 weeks
Asthma Symptom Score Evening
Time frame: 2 weeks
Asthma Symptom Score Total
Time frame: 2 weeks
Rescue Medication Morning
Time frame: 2 weeks
Rescue Medication Evening
Time frame: 2 weeks
Rescue Medication Total
Time frame: 2 weeks
Peak Exploratory Flow (PEF) Morning
Time frame: 2 weeks

Results and safety

Results posted to the registry on 7 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Budesonide Hydrofluoroalkane (HFA) First, Then Budesonide CFC	49	44
Budesonide Chlorofluorocarbon (CFC) First, Then Budesonide HFA	50	45

Primary outcome: PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume)

Time frame: Baseline and week 2. Geometric mean (95% Confidence Interval). Unit: Ratio

Measure	Budesonide Hydrofluoroalkane (HFA) 100 n = 80	Budesonide HFA 400 n = 79	Budesonide Chlorofluorocarbon(CFC) 100 n = 79	Budesonide CFC 400 n = 78
Value	1.546 (1.343 to 1.780)	2.163 (1.877 to 2.494)	1.673 (1.449 to 1.928)	2.079 (1.801 to 2.401)

Population analysed: Full analysis set (FAS). The FAS was defined as all randomised patients who contributed data from at least one period (ie data from both low and high dose of one inhaler).

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Budesonide Hydrofluoroalkane (HFA) 100	0 of 86 (0%)	0 of 86 (0%)	Not reported
Budesonide HFA 400	1 of 81 (1.2%)	0 of 81 (0%)	Not reported
Budesonide Chlorofluorocarbon (CFC) 100	2 of 85 (2.4%)	0 of 85 (0%)	Not reported
Budesonide CFC 400	0 of 79 (0%)	0 of 79 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28065396Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
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Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
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RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian Lipworth, PhD, MD principal investigator

Asthma and Allergy Research Group Division of Medicine and Therapeutics Ninewells Hospital and Medical School University of Dundee

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide HFA and Budesonide CFC in people with Asthma, run by AstraZeneca at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PC 20 Methacholine (Provocative Concentration of Methacholine Causing 20 % Fall in FEV1(Forced Expiratory Volume) (time frame: Baseline and week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00667992, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.