AsthmaPhase 3NCT00525772
Effect of Ciclesonide on Exercise Induced Bronchoconstriction
A Phase 3 study testing ciclesonide in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to study the effects of once daily inhaled ciclesonide at varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and sputum characteristics. Read more about this study
- Who is it for?
- Ages 12 to 30 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
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2001to Nov 2007
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- stable asthma not on maintenance asthma medications
- exercise induced bronchoconstriction on dry air exercise challenge.
Who cannot join
- other significant co-morbidity or treatments that might interfere with the conduct or results of the study
- fail to return to baseline after a maximum washout period of 8 weeks
- unable to perform the procedures of the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to study the effects of once daily inhaled ciclesonide at varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and sputum characteristics.
Read the detailed description
To study the effects of 4 doses of ciclesonide on exercise-induced bronchoconstriction, bronchial responsiveness to mannitol, sputum parameters and other parameters of asthma control in asthmatic patients. The primary aim was to evaluate exercise-induced bronchoconstriction as a method of determining the dose and time responses of inhaled corticosteroid therapy. The secondary aims were to evaluate the dose and time responses of sputum parameters and responsiveness to mannitol to inhaled corticosteroid therapy. Furthermore to explore the relationship(s) between exercise induced bronchoconstriction, sputum parameters and mannitol responsiveness.
- Conditions
- Asthma
- Being tested
- ciclesonide
- Keywords
- asthma, exercise induced bronchoconstriction, sputum eosinophils
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ciclesonideDrug
Also called ciclesonide (Alvesco)
low dose- 50ug and 200ug
ciclesonideDrug
Also called ciclesonide (Alvesco)
high dose- 100ug and 400ug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ciclesonide 50 and 200ug Receives: Drug: ciclesonide |
| 2 | Active comparator | ciclesonide 100ug and 400ug Receives: Drug: ciclesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value
Measured: at 1 week of treatment
Secondary outcomes (1)
Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value.
Measured: after 1, 2, 3, weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startNov 2001
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Kolding Sygehus, Takeda
- Investigators
- Paul O'Byrne, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525772
- Sponsor's protocol ID
- BY/M1-121
- Other IDs
- OBCIEX
- Status last verified
- Oct 2009
- First submitted
- 4 Sep 2007
- Last updated
- 21 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Subbarao P, Duong M, Adelroth E, Otis J, Obminski G, Inman M, Pedersen S, O'byrne PM. Effect of ciclesonide dose and duration of therapy on exercise-induced bronchoconstriction in patients with asthma. J Allergy Clin Immunol. 2006 May;117(5):1008-13. doi: 10.1016/j.jaci.2005.11.048.
PubMed 16675326Duong M, Subbarao P, Adelroth E, Obminski G, Strinich T, Inman M, Pedersen S, O'Byrne PM. Sputum eosinophils and the response of exercise-induced bronchoconstriction to corticosteroid in asthma. Chest. 2008 Feb;133(2):404-11. doi: 10.1378/chest.07-2048. Epub 2007 Dec 10.
PubMed 18071011
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ciclesonide on Exercise Induced Bronchoconstriction
- ClinicalTrials.gov ID
- NCT00525772
- Acronym / sponsor ID
- BY/M1-121
- Conditions
- Asthma
- Keywords
- asthma, exercise induced bronchoconstriction, sputum eosinophils
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Kolding Sygehus, Takeda
- Study start
- Nov 2001
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Sep 2007 (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 purpose of this study is to study the effects of once daily inhaled ciclesonide at varying doses on exercise provoked asthma symptoms, fall in lung function after exercise and sputum characteristics.
Detailed description
To study the effects of 4 doses of ciclesonide on exercise-induced bronchoconstriction, bronchial responsiveness to mannitol, sputum parameters and other parameters of asthma control in asthmatic patients. The primary aim was to evaluate exercise-induced bronchoconstriction as a method of determining the dose and time responses of inhaled corticosteroid therapy. The secondary aims were to evaluate the dose and time responses of sputum parameters and responsiveness to mannitol to inhaled corticosteroid therapy. Furthermore to explore the relationship(s) between exercise induced bronchoconstriction, sputum parameters and mannitol responsiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: ciclesonideciclesonide 50 and 200ug |
| 2 | Active comparator | Drug: ciclesonideciclesonide 100ug and 400ug |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- stable asthma not on maintenance asthma medications
- exercise induced bronchoconstriction on dry air exercise challenge.
Key exclusion criteria (3 listed)
- other significant co-morbidity or treatments that might interfere with the conduct or results of the study
- fail to return to baseline after a maximum washout period of 8 weeks
- unable to perform the procedures of the study
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 |
|---|---|---|
| ciclesonideAlso: ciclesonide (Alvesco)low dose- 50ug and 200ug | Drug | 1 |
| ciclesonideAlso: ciclesonide (Alvesco)high dose- 100ug and 400ug | Drug | 2 |
Primary outcome
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value
Time frame: at 1 week of treatment
1 secondary outcome
Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value.
Time frame: after 1, 2, 3, weeks of treatment
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 21 Oct 2009.
- Background: PubMed 16675326Subbarao P, Duong M, Adelroth E, Otis J, Obminski G, Inman M, Pedersen S, O'byrne PM. Effect of ciclesonide dose and duration of therapy on exercise-induced bronchoconstriction in patients with asthma. J Allergy Clin Immunol. 2006 May;117(5):1008-13. doi: 10.1016/j.jaci.2005.11.048.
- Derived from this study: PubMed 18071011Duong M, Subbarao P, Adelroth E, Obminski G, Strinich T, Inman M, Pedersen S, O'Byrne PM. Sputum eosinophils and the response of exercise-induced bronchoconstriction to corticosteroid in asthma. Chest. 2008 Feb;133(2):404-11. doi: 10.1378/chest.07-2048. Epub 2007 Dec 10.
Related trials for Asthma
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
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.
Paul O'Byrne, MD principal investigator
McMaster University
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 in people with Asthma, run by Hamilton Health Sciences Corporation at 1 site in Canada.
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 2 inclusion and 3 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 21 Oct 2009. 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 Canada. 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?
change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value (time frame: at 1 week of treatment). 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 NCT00525772, which also lists 2 linked publications.
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 21 Oct 2009.