AsthmaPhase 3NCT00392288

Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.

A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 6 sites in 6 countries.

Completed

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

Trial summary

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma. Secondary objective: To assess the safety and tolerability of ciclesonide. Read more about this study

Who is it for?: Ages 4 to 11 years
Conditions the study is for: Asthma
What is being tested?: Ciclesonide
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 528 participants
Where: 6 sitesin 6 countries
Study dates: Sep 2006to Feb 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 4 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

History of persistent bronchial asthma for at least 3 months prior to screening;
For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Who cannot join

Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;
Use of injectable or oral corticosteroids within one month prior to screening, or more than 3 bursts) within 6 months prior to screening;

Trial locations and contacts

6 sites in 6 countries.

Country

City, postcode or hospital

6 sites in 6 countries

United States1 site

sanofi-aventis, US
Bridgewater, New Jersey, 08807

Other trials in United States

Hungary1 site

Sanofi-Aventis Hungaria
Budapest

Other trials in Hungary

Mexico1 site

Sanofi-Aventis
México

Other trials in Mexico

Poland1 site

sanofi-aventis Poland
Warsaw

Other trials in Poland

Russia1 site

Sanofi-Aventis Administrative Office
Moscow

Other trials in Russia

South Africa1 site

sanofi-aventis South Africa
Midrand

Other trials in South Africa

About this study

Official title: A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma.

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.

Conditions: Asthma
Being tested: Ciclesonide, Placebo
Keywords: Bronchial Asthma
Medical subject headings: Asthma

What participants receive

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

CiclesonideDrug
Ciclesonide MDI 40 µg BID over twelve weeks
CiclesonideDrug
Ciclesonide MDI 80 µg BID over twelve weeks
PlaceboDrug
Placebo MDI over twelve weeks

Study groups in NCT00392288
Study group	Role	What they receive
Placebo MDI	Placebo comparator	double-blind Receives: Drug: Placebo
Ciclesonide MDI 40 µg BID	Experimental	double-blind Receives: Drug: Ciclesonide
Ciclesonide MDI 80 µg BID	Experimental	double-blind Receives: Drug: Ciclesonide

What is being measured

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

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.
Measured: Baseline and Week 12

Secondary outcomes (2)

Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
Change in total daily asthma symptom score from baseline to week 12. 5-Point, ordinal scale specifying patient's experience of symptoms during day and night from 0 (no symptoms) to 4 (symptoms that prevent the patient from engaging in daily activities or sleep)
Measured: Baseline and Week 12
Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
Change in albuterol/salbutamol use from baseline to week 12
Measured: Baseline and Week 12

Timeline

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

Sep 2006Feb 2008

First posted25 Oct 2006 (estimated)
Study startSep 2006
Primary completionFeb 2008
Study completionFeb 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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 528 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00392288
Sponsor's protocol ID: EFC6695
Other IDs: XRP1526
Status last verified: Sep 2016
First submitted: 24 Oct 2006
Last updated: 1 Feb 2017
Results posted: Yes, on ClinicalTrials.gov

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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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
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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: A Multicenter, Multi-national, Randomized, Double-blind, Placebo-controlled, Study to Assess the Efficacy and Safety of Ciclesonide Metered-dose Inhaler (MDI) at 80 μg BID or 40 μg BID for 12 Weeks in Patients Aged 4 to <12 Years With Persistent Asthma.
ClinicalTrials.gov ID: NCT00392288
Acronym / sponsor ID: EFC6695
Conditions: Asthma
Keywords: Bronchial Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 528 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Sep 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 25 Oct 2006 (estimated)
Results: Posted 30 Dec 2009

Clinical summary

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

Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.

Secondary objective: To assess the safety and tolerability of ciclesonide.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo MDI	Placebo comparator	Drug: Placebodouble-blind
Ciclesonide MDI 40 µg BID	Experimental	Drug: Ciclesonidedouble-blind
Ciclesonide MDI 80 µg BID	Experimental	Drug: Ciclesonidedouble-blind

Who may qualify

Ages: 4 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

History of persistent bronchial asthma for at least 3 months prior to screening;
For patients with persistent bronchial asthma and being treated with a controller therapy: Documented use of an inhaled steroid or Singulair® 5mg once daily;
For patients with persistent bronchial asthma and not being treated with controller therapy: Patients may have documented use of a reliever therapy such as albuterol/salbutamol or may be untreated;
Morning Peak Expiratory Flow (AM PEF) of ≤90% of predicted values from the in-clinic spirometry after a 6 hour withhold of albuterol/salbutamol;
Only patients aged between 6 to <12 years must have a forced expiratory volume in one second (FEV1) of ≥50% to ≤85% of predicted normal after a 6 hour withhold of albuterol/salbutamol

Key exclusion criteria (6 listed)

Nocturnal awakenings for asthma which require treatment with albuterol/salbutamol for 4 or more nights out of the last 7 days of the screening period;
Use of more than 8 puffs/day of albuterol/salbutamol on 3 or more consecutive days within the last 7
Upper or lower respiratory tract infection within 4 weeks prior to screening and during screening period;
History of life-threatening asthma, including a history of significant hypercarbia (pCO2 >45 mmHg), prior intubation, respiratory arrest, or seizures as a result of an exacerbation of asthma;
More than 3 in-patient hospitalization or emergency care visits due to asthma exacerbations in the year prior to screening;

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
CiclesonideCiclesonide MDI 40 µg BID over twelve weeks	Drug	Ciclesonide MDI 40 µg BID
CiclesonideCiclesonide MDI 80 µg BID over twelve weeks	Drug	Ciclesonide MDI 80 µg BID
PlaceboPlacebo MDI over twelve weeks	Drug	Placebo MDI

Primary outcome

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.
Time frame: Baseline and Week 12
Change in FEV1 (Percent of predicted) from baseline to week 12. FEV1 was measured only in children between 6 to <12 years only. Least Squares Mean were adjusted for Baseline FEV1, age [yrs], pooled center, previous corticosteroid therapy and holding chamber.

2 secondary outcomes

Change From Baseline in Total Daily Asthma Symptom Score at Week 12.
Time frame: Baseline and Week 12
Change From Baseline in Use of Albuterol/Salbutamol at Week 12.
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 30 Dec 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Metered Dose Inhaler (MDI)	175	143
Ciclesonide MDI 40 µg BID	177	155
Ciclesonide MDI 80 µg BID	176	159

Primary outcome: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12.

Time frame: Baseline and Week 12. Least squares mean (Standard Error). Unit: Percent of predicted FEV1

Measure	Placebo Metered Dose Inhaler (MDI) n = 136	Ciclesonide MDI 40 µg BID n = 138	Ciclesonide MDI 80 µg BID n = 146
Value	5.2 (1.06)	5.3 (1.06)	7.7 (1.06)

Placebo Metered Dose Inhaler (MDI) vs Ciclesonide MDI 40 µg BID vs Ciclesonide MDI 80 µg BID: p = 0.2696, ANCOVA
Placebo Metered Dose Inhaler (MDI) vs Ciclesonide MDI 80 µg BID: p = 0.0703, ANCOVA
Placebo Metered Dose Inhaler (MDI) vs Ciclesonide MDI 40 µg BID: p = 0.9146, ANCOVA

Population analysed: Analyses are based on children of the ITT population. It includes all randomized patients who have a baseline and a valid post-randomization lung function measurement. The primary analysis was restricted to an age range between 6 and \<12 years.

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
Placebo Metered Dose Inhaler (MDI)	1 of 172 (0.6%)	53 of 172 (30.8%)	Not reported
Ciclesonide MDI 40 µg BID	1 of 174 (0.6%)	38 of 174 (21.8%)	Not reported
Ciclesonide MDI 80 µg BID	4 of 175 (2.3%)	28 of 175 (16%)	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.

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
Asthma Control
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

6 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 6 sites in 6 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 5 inclusion and 6 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 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 6 sites in United States, Hungary, Mexico, Poland, Russia and 1 more country. 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. Some participants in this study may receive a placebo. 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 30 Dec 2009). 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?

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at Week 12. (time frame: Baseline and Week 12). 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 NCT00392288.

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.