AsthmaPhase 2MinoNCT00456677
Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
A Phase 2 study testing minocycline in people with Asthma, run by State University of New York - Downstate Medical Center at 1 site in United States.
Trial summary
Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1996to 1 Oct 2007
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult asthmatics
- History of or current use of oral steroids to control symptoms
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Downstate Medical Center
Brooklyn, New York, 11203
About this study
Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.
Read the detailed description
This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).
- Conditions
- Asthma
- Being tested
- minocycline, Placebos
- Keywords
- minocycline, asthma, oral corticosteroids
- Medical subject headings
- Asthma, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minocyclineDrug
Also called Minocin
addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
PlacebosDrug
Also called oral placebo capsules
Addition of oral placebo capsule in addition to standard of care regimen
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Addition of minocycline 150 mg po twice daily to current asthma treatment regimen. Receives: Drug: minocycline |
| Placebos | Placebo comparator | Addition of placebo capsules po twice daily to current asthma treatment regimen Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in oral steroid therapy requirements.
Measured: 8 weeks
Secondary outcomes (4)
improvement in symptoms scores
Asthma Quality of Lifes Scores (AQLQ)
Measured: 8 weeks
improvement in spriometric parameters
improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75
Measured: 8 weeks
improvement in morning and evening peak flow
Measured: 8 weeks
decrease in rescue inhaler usage
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 posted5 Apr 2007 (estimated)
- Study startJun 1996
- Primary completion1 Oct 2007
- Study completion1 Oct 2007
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind, placebo-controlled. crossover study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Downstate Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rauno Joks, State University of New York - Downstate Medical Center
- Investigators
- Rauno Joks, MD, Principal investigator, State University of New York - Downstate Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456677
- Sponsor's protocol ID
- Heikki31
- Acronym
- Mino
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2007
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Utility of Minocycline as an Anti-Inflammatory Agent in the Treatment of Asthma
- ClinicalTrials.gov ID
- NCT00456677
- Acronym / sponsor ID
- Mino / Heikki31
- Conditions
- Asthma
- Keywords
- minocycline, asthma, oral corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- State University of New York - Downstate Medical CenterUniversity, hospital or other
- Study start
- Jun 1996
- Primary completion
- 1 Oct 2007 (actual)
- Study completion
- 1 Oct 2007 (actual)
- First posted
- 5 Apr 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.
Trial of effects of minocycline as "add-on" therapy to adults with asthma with a history of requiring at least one episode of oral steroid therapy to control the disease.
Detailed description
This is a double-blind, placebo-controlled crossover study of adult asthmatics given minocycline 150 mg po BID or placebo as add-on therapy for eight weeks each. Each eight week arm is separated by a four week wash-out. Spirometry is performed at the baseline and end of each arm. Daily symptoms scores, peak flow rates, and oral steroid requirements are recorded. A standardized asthma quality of life symptoms assessment is made every four weeks (AQLQ, Juniper).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Double blind, placebo-controlled. crossover study
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: minocyclineAddition of minocycline 150 mg po twice daily to current asthma treatment regimen. |
| Placebos | Placebo comparator | Drug: PlacebosAddition of placebo capsules po twice daily to current asthma treatment regimen |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult asthmatics
- History of or current use of oral steroids to control symptoms
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| minocyclineAlso: Minocinaddition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen. | Drug | Minocycline |
| PlacebosAlso: oral placebo capsulesAddition of oral placebo capsule in addition to standard of care regimen | Drug | Placebos |
Primary outcome
Decrease in oral steroid therapy requirements.
Time frame: 8 weeks
4 secondary outcomes
improvement in symptoms scores
Time frame: 8 weeks
improvement in spriometric parameters
Time frame: 8 weeks
improvement in morning and evening peak flow
Time frame: 8 weeks
decrease in rescue inhaler usage
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 18 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Rauno Joks, MD principal investigator
State University of New York - Downstate Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing minocycline in people with Asthma, run by State University of New York - Downstate Medical Center at 1 site in United States.
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 1 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 18 Apr 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Decrease in oral steroid therapy requirements. (time frame: 8 weeks). 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 18 Apr 2017.