AsthmaPhase 3NCT00306163

Responsiveness of Lower Airways in Adult Patients (18-60 Years) With Stable Asthma After Treatment With Ciclesonide and Fluticasone Propionate (BY9010/NL-101)

A Phase 3 study testing Ciclesonide and Fluticasone in people with Asthma, run by AstraZeneca at 1 site in Netherlands.

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

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Asthma
What is being tested?: Ciclesonide and Fluticasone
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteNetherlands
Study dates: May 2006to Sep 2008
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 60 years
All sexes
No healthy volunteers
Adult

Main Inclusion Criteria:

History of bronchial asthma
FEV1 > 1.20 L
Positive Skin Prick Test
Not more than 500 mcg/day fluticasone propionate or equivalent for at least 28 days prior to baseline visit

Main Exclusion Criteria:

Clinically relevant abnormal laboratory values
Concomitant severe diseases, diseases expected to interfere with the outcome of the study and diseases which are contra-indications for the use of inhaled steroids
Chronic obstructive pulmonary disease (COPD) and /or other relevant lung diseases
One asthma exacerbation within 2 months or more than 3 exacerbations within the last year prior to baseline visit
Current smokers or ex-smokers with more than 10 pack years, or having smoked within 1 year prior to baseline visit
Positive response to saline challenge at baseline visits
Positive bronchial hyperresponsiveness

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Altana Pharma/Nycomed
RB Groningen, 9700

Other trials in Netherlands

About this study

Official title: Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.

The aim of this study is to compare the responsiveness of lower airways in adult patients with stable asthma after treatment with ciclesonide and fluticasone propionate. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily at one dose level, fluticasone propionate will be inhaled twice daily at one dose level. The study duration consists of a baseline period (5 weeks) and a treatment period (5 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Conditions: Asthma
Being tested: Ciclesonide, Fluticasone
Keywords: Asthma, AMP, Ciclesonide, Fluticasone propionate
Medical subject headings: Asthma

What participants receive

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

CiclesonideDrug
inhaled Ciclesonide 160 µg, once daily in the morning
FluticasoneDrug
inhaled Fluticasone 100 µg, twice daily

Study groups in NCT00306163
Study group	Role	What they receive
1	Active comparator	Ciclesonide 160 µg Receives: Drug: Ciclesonide
2	Active comparator	Fluticasone 100 µg Receives: Drug: Fluticasone

What is being measured

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

PC20 AMP (Post-treatment Compared to Baseline)
Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron
Measured: Baseline and 5 weeks

Secondary outcomes (2)

Δ (FVC/SVC) at PC20 (AMP)
Change between baseline and post-treatment of the ratio of Forced Vital Capacity (FVC) and Slow Vital Capacity at PC20. Measured with either small or large partical size AMP.
Measured: Baseline and 5 weeks
Safety and Tolerability
Measured: 5 weeks

Timeline

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

May 2006Sep 2008

First posted23 Mar 2006 (estimated)
Study startMay 2006
Primary completionAug 2008
Study completionSep 2008

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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00306163
Sponsor's protocol ID: BY9010/NL-101
Status last verified: Sep 2016
First submitted: 22 Mar 2006
Last updated: 1 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. doi: 10.1183/09031936.00204109. Epub 2010 Jul 1.
PubMed 20595155

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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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nebulizer Trial: Evaluation of the Influence of Particle Size of Aerosolized AMP on Bronchial Responsiveness in Patients With Asthma and the Effects of Treatment With Ciclesonide Versus Fluticasone.
ClinicalTrials.gov ID: NCT00306163
Acronym / sponsor ID: BY9010/NL-101
Conditions: Asthma
Keywords: Asthma, AMP, Ciclesonide, Fluticasone propionate
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Aug 2008 (actual)
Study completion: Sep 2008 (actual)
First posted: 23 Mar 2006 (estimated)
Results: Posted 26 Apr 2010

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: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: CiclesonideCiclesonide 160 µg
2	Active comparator	Drug: FluticasoneFluticasone 100 µg

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

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
Ciclesonideinhaled Ciclesonide 160 µg, once daily in the morning	Drug	1
Fluticasoneinhaled Fluticasone 100 µg, twice daily	Drug	2

Primary outcome

PC20 AMP (Post-treatment Compared to Baseline)
Time frame: Baseline and 5 weeks
Mean change of Provocative concentration of Adenosine-5'-monophosphate (PC20 AMP) leading to a 20 percent decrease in Forced expiratory volume in one second (FEV1) between post-treatment and baseline using two different particle sizes. - Small particles = Mass mean aerodynamic diameter (MMAD) of approximately 1.04-1.08 micron - Large particles = MMAD of approximately 9.9-10.6 micron

2 secondary outcomes

Δ (FVC/SVC) at PC20 (AMP)
Time frame: Baseline and 5 weeks
Safety and Tolerability
Time frame: 5 weeks

Results and safety

Results posted to the registry on 26 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ciclesonide	19	19
Fluticasone	18	18

Primary outcome: PC20 AMP (Post-treatment Compared to Baseline)

Time frame: Baseline and 5 weeks. Mean (Standard Deviation). Unit: Logarithm (mg/mL)

Measure	Ciclesonide n = 11	Fluticasone n = 12
Baseline PC20 small-particle AMP	4.9 (3.7)	5.2 (2.1)
Baseline PC20 large-particle AMP	3.7 (2.6)	3.0 (2.4)
Post-Treatment PC20 small-particle AMP	6.6 (2.0)	6.0 (2.7)
Post-Treatment PC20 large-particle AMP	4.5 (2.3)	4.3 (2.4)

Population analysed: The analyses on treatment effects were performed on all subjects who reached a PC20\<640mg/mL.

2 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
Ciclesonide	0 of 19 (0%)	2 of 19 (10.5%)	Not reported
Fluticasone	0 of 18 (0%)	2 of 18 (11.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 20595155Cohen J, Postma DS, Douma WR, Vonk JM, De Boer AH, ten Hacken NH. Particle size matters: diagnostics and treatment of small airways involvement in asthma. Eur Respir J. 2011 Mar;37(3):532-40. doi: 10.1183/09031936.00204109. Epub 2010 Jul 1.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

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.

AstraZeneca AstraZeneca study director

AstraZeneca

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciclesonide and Fluticasone in people with Asthma, run by AstraZeneca at 1 site in Netherlands.

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

Who may be eligible to take part?

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 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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 26 Apr 2010). 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?

PC20 AMP (Post-treatment Compared to Baseline) (time frame: Baseline and 5 weeks). 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 NCT00306163, 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 1 Feb 2017.