AsthmaPhase 3NCT02100267
A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
A Phase 3 study testing Methacholine Chloride (SK-1211) in people with Asthma, run by Sanwa Kagaku Kenkyusho Co., Ltd. at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma Read more about this study
- Who is it for?
- Ages 20 to 64 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
- Not given
- Where
- 1 siteJapan
- Study dates
- Apr 2014to Sep 2014
- 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 20 to 64 years
- All sexes
- Adult
Who may be able to join
- FEV1/forced vital capacity(FVC) must be 70% or more
- <10% decrease in FEV1 in response to inhalation of normal saline
Who cannot join
- Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
- Heart attack or stroke in last 3 months
- Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
Trial locations and contacts
1 site in 1 country.
Japan1 site
Showa University Clinical Research Center
Setagaya-ku, Tokyo, 157-8577
About this study
The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult 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
Subjects received saline and 0.039-25 mg/mL of Methacholine chloride
| Study group | Role | What they receive |
|---|---|---|
| Asthma patients | Experimental | Not described Receives: Drug: Methacholine Chloride (SK-1211) |
| Healthy volunteers | Experimental | Not described Receives: Drug: Methacholine Chloride (SK-1211) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
Measured: Visit 2 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
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.
- 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
- Diagnosis
Sponsor and investigators
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100267
- Sponsor's protocol ID
- MC1001
- Status last verified
- Mar 2014
- First submitted
- 24 Mar 2014
- Last updated
- 17 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
- ClinicalTrials.gov ID
- NCT02100267
- Acronym / sponsor ID
- MC1001
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Mar 2014 (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 evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma
Study design
- Primary purpose
- Diagnosis
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma patients | Experimental | Drug: Methacholine Chloride (SK-1211) |
| Healthy volunteers | Experimental | Drug: Methacholine Chloride (SK-1211) |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (2 listed)
- FEV1/forced vital capacity(FVC) must be 70% or more
- <10% decrease in FEV1 in response to inhalation of normal saline
Key exclusion criteria (3 listed)
- Moderate airflow limitation (FEV1 < 60% predicted or < 1.5 L)
- Heart attack or stroke in last 3 months
- Uncontrolled hypertension, systolic BP>200, or diastolic BP>100
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)Subjects received saline and 0.039-25 mg/mL of Methacholine chloride | Drug | Asthma patients, Healthy volunteers |
Primary outcome
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
Time frame: Visit 2 (Day 1)
Provocative concentration causing a 20% fall(PC20) will be captured once at visit 2.
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 17 Nov 2014.
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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 Sanwa Kagaku Kenkyusho 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 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 17 Nov 2014. 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?
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?
Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL) (time frame: Visit 2 (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 17 Nov 2014.