AsthmaPhase 3NCT00305461
Effect of Ciclesonide on Quality of Life in Patients With Moderate Persistent Asthma (21 to 65 y) (BY9010/AR-101)
A Phase 3 study testing Ciclesonide in people with Asthma, run by AstraZeneca at 12 sites in Argentina.
Trial summary
The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Ciclesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 12 sitesArgentina
- Study dates
- Feb 2006to Feb 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Written informed consent
- Good health with the exception of asthma
- Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
- Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
- FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
- Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
- Patients compliant to recommended pre-treatment
Main Exclusion Criteria:
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Chronic obstructive pulmonary disease (COPD)
- Hospitalization within previous four weeks from baseline
- Hospitalization due to asthma within the last twelve months
- Asthma exacerbation within two months previous to baseline
- History of almost fatal asthma at any moment
- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
- Exacerbation of asthma within 2 months prior to entry into the baseline period
- Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Argentina12 sites
Altana Pharma/Nycomed
Buenos Aires, B1902CSK
Altana Pharma/Nycomed
Buenos Aires, B7540GHQ
Altana Pharma/Nycomed
Buenos Aires, B8000AAT
Altana Pharma/Nycomed
Cap. Fed., C1117ABE
Altana Pharma/Nycomed
Cap. Fed., C1121ABE
Altana Pharma/Nycomed
Cap. Fed., C1221ADC
Altana Pharma/Nycomed
Cap. Fed., C1427ARN
Altana Pharma/Nycomed
Córdoba, X5000BFB
Altana Pharma/Nycomed
Córdoba, X5016KEH
Altana Pharma/Nycomed
Mendoza, M5500CCG
Altana Pharma/Nycomed
San Miguel de Tucumán, T4146DAL
Altana Pharma/Nycomed
Santa Fe, S2000DSV
About this study
Official title: A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma.
The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).
- Conditions
- Asthma
- Being tested
- Ciclesonide
- Keywords
- Asthma, Quality of Life, Ciclesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclesonideDrug
Effect of Ciclesonide on Quality of Life
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclesonide 160µg Receives: Drug: Ciclesonide |
| 2 | Active comparator | Ciclesonide 320µg Receives: Drug: Ciclesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in Quality of Life from AQLQ(S) (T end versus T0)
Measured: 8 weeks
time to first exacerbation
Measured: 8 weeks
differences in FEV1 and FVC from spirometry (T end vs T0).
Measured: 8 weeks
Secondary outcomes (9)
percentage of days on which patients perceived asthma control
Measured: 8 weeks
percentage of asthma symptoms free days
Measured: 8 weeks
percentage of rescue medication-free days
Measured: 8 weeks
percentage of nocturnal awakening-free days
Measured: 8 weeks
asthma symptom score (daytime score, nighttime score, total score)
Measured: 8 weeks
use of rescue medication
Measured: 8 weeks
PEF from spirometry
Measured: 8 weeks
morning and evening PEF from diary
Measured: 8 weeks
diurnal PEF fluctuation.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2006 (estimated)
- Study startFeb 2006
- Primary completionMar 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AstraZeneca AstraZeneca, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00305461
- Sponsor's protocol ID
- BY9010/AR-101
- Status last verified
- Sep 2016
- First submitted
- 21 Mar 2006
- Last updated
- 5 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on the Impact of Two Different Doses of Ciclesonide (160 mcg/Day and 320 mcg/Day) Administered in the Evening on Quality of Life in Patients With Moderate Persistent Asthma.
- ClinicalTrials.gov ID
- NCT00305461
- Acronym / sponsor ID
- BY9010/AR-101
- Conditions
- Asthma
- Keywords
- Asthma, Quality of Life, Ciclesonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 22 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare the effect of ciclesonide on quality of life, pulmonary function and time to first exacerbation in patients with moderate persistent asthma. Ciclesonide will be administered once daily in the evening at two dose levels. The study duration consists of a baseline period (2 weeks) and a treatment period (8 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: CiclesonideCiclesonide 160µg |
| 2 | Active comparator | Drug: CiclesonideCiclesonide 320µg |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| CiclesonideEffect of Ciclesonide on Quality of Life | Drug | 1, 2 |
Primary outcome
differences in Quality of Life from AQLQ(S) (T end versus T0)
Time frame: 8 weeks
time to first exacerbation
Time frame: 8 weeks
differences in FEV1 and FVC from spirometry (T end vs T0).
Time frame: 8 weeks
9 secondary outcomes
percentage of days on which patients perceived asthma control
Time frame: 8 weeks
percentage of asthma symptoms free days
Time frame: 8 weeks
percentage of rescue medication-free days
Time frame: 8 weeks
percentage of nocturnal awakening-free days
Time frame: 8 weeks
asthma symptom score (daytime score, nighttime score, total score)
Time frame: 8 weeks
use of rescue medication
Time frame: 8 weeks
PEF from spirometry
Time frame: 8 weeks
morning and evening PEF from diary
Time frame: 8 weeks
diurnal PEF fluctuation.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- BY9010-AR-101-RDS-2009-06-19.pdfLink provided by the sponsor.
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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.
AstraZeneca AstraZeneca study director
AstraZeneca
12 sites 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 in people with Asthma, run by AstraZeneca at 12 sites in Argentina.
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 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Argentina. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
differences in Quality of Life from AQLQ(S) (T end versus T0) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2016.