Asthma
Conditions
Keywords
minocycline, asthma, oral corticosteroids
Brief 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.
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).
Interventions
DRUGminocycline
addition of antibiotic minocycline as antiinflammatory agent in addition to standard of care regimen.
DRUGPlacebos
Addition of oral placebo capsule in addition to standard of care regimen
Sponsors
State University of New York - Downstate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Double blind, placebo-controlled. crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult asthmatics * History of or current use of oral steroids to control symptoms
Exclusion criteria
* Pregnant women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in oral steroid therapy requirements. | 8 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| improvement in symptoms scores | 8 weeks | Asthma Quality of Lifes Scores (AQLQ) |
| improvement in spriometric parameters | 8 weeks | improvement in spirometric parameters including FEV1, FVC, FEV1/FVC, FEF25-75 |
| improvement in morning and evening peak flow | 8 weeks | — |
| decrease in rescue inhaler usage | 8 weeks | — |
Countries
United States
Outcome results
None listed