AsthmaPhase 3NCT02097537
Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
A Phase 3 study testing Methacholine Chloride (SK-1211) in people with Asthma, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Methacholine Chloride (SK-1211)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Feb 2014to Jul 2014
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of bronchial asthma
- FEV1/FVC must be 70% or more
- <10% decrease in FEV1 in response to inhalation of normal saline
Who cannot join
- Moderate or severe airflow limitation（FEV1<60% predicted）
- Heart attack or stroke in last 3 months
- Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
- known aortic aneurysm
Trial locations and contacts
1 site in 1 country.
About this study
The Purpose of this study is to evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
- Conditions
- Asthma
- Being tested
- Methacholine Chloride (SK-1211)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacholine Chloride (SK-1211)Drug
| Study group | Role | What they receive |
|---|---|---|
| Methacholine Chloride | Experimental | children with bronchial asthma Receives: Drug: Methacholine Chloride (SK-1211) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer.
For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more.
The concentration of methacholine causing 20% fall in FEV1 is PC20.
Measured: Visit 1 (Day 1)
Secondary outcomes (2)
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
Measured: Visit 1 (Day 1)
The Summary Statistics of PC20
PC20 : the concentration of methacholine causing 20% fall in FEV1.
Measured: Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
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.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097537
- Sponsor's protocol ID
- MC1002
- Status last verified
- Feb 2017
- First submitted
- 19 Mar 2014
- Last updated
- 29 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Methacholine Chloride Inhalation Challenge in Children With Bronchial Asthma
- ClinicalTrials.gov ID
- NCT02097537
- Acronym / sponsor ID
- MC1002
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Santen Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 14 Feb 2017
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 evaluate the safety and efficacy of SK-1211 inhalation challenge in children with bronchial asthma.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methacholine Chloride | Experimental | Drug: Methacholine Chloride (SK-1211)children with bronchial asthma |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of bronchial asthma
- FEV1/FVC must be 70% or more
- <10% decrease in FEV1 in response to inhalation of normal saline
Key exclusion criteria (4 listed)
- Moderate or severe airflow limitation（FEV1<60% predicted）
- Heart attack or stroke in last 3 months
- Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
- known aortic aneurysm
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 |
|---|---|---|
| Methacholine Chloride (SK-1211) | Drug | Methacholine Chloride |
Primary outcome
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL
Time frame: Visit 1 (Day 1)
The methacholine challenge test is for assessment of bronchial sensitivity, it is assessed by FEV1 (Forced Expiratory Volume in one second) with spirometer. For measurement of FEV1, a patient is inhaled saline as baseline and each dose of methacholine which be gradually diluted, inhalations are discontinued with a drop in FEV1 of 20% or more. The concentration of methacholine causing 20% fall in FEV1 is PC20.
2 secondary outcomes
The Rate of Subjects Whose FEV1 Falls More Than 20% From Baseline Before the Highest Concentration Inhalation
Time frame: Visit 1 (Day 1)
The Summary Statistics of PC20
Time frame: Visit 1 (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Methacholine Chloride (SK-1211) in people with Asthma, run by Santen Pharmaceutical Co., Ltd. at 1 site in Japan.
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 29 Mar 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 Japan. 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 14 Feb 2017). 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?
The Rate of Number of Subjects Whose PC20 is Less Than 8 mg/mL (time frame: Visit 1 (Day 1)). 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 29 Mar 2017.