N/A
N=55
Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients
Asthma · Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01221350 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Spirometric FVC Values at Baseline — 2.74; 3.07 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lipoic acid (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro Universitario de Ciencias de la Salud, Mexico
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spirometric FVC Values at Baseline |
2.74; 3.07 | — |
| PRIMARY Spirometric FVC Values at Endpoint |
2.82; 3.06 | — |
| PRIMARY Spirometric FEV1 Values at Baseline |
2.01; 2.37 | — |
| PRIMARY Spirometric FEV1 Values at Endpoint |
2.26; 2.35 | — |
| PRIMARY Spirometric FEF Values at Baseline |
4.89; 6.09 | — |
| PRIMARY Spirometric FEF Values at Endpoint |
5.47; 6.10 | — |
| SECONDARY Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline |
81.42; 35.77 | — |
| SECONDARY Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint |
58.6; 37.5 | — |
| SECONDARY Induced Sputum Carbonylated Proteins at Baseline |
7.5; 10.12 | — |
| SECONDARY Induced Sputum Carbonylated Proteins at Endpoint |
3.24; 4.21 | — |
| SECONDARY Induced Sputum Eosinophils at Baseline |
12.88; 6.10 | — |
| SECONDARY Induced Sputum Eosinophils at Endpoint |
6.39; 5.68 | — |
| SECONDARY Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline |
37.77; 39.90 | — |
| SECONDARY Inflammatory IL-4 Sputum Levels at Endpoint |
14.53; 23.19 | — |
| SECONDARY Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline |
13.65; 14.46 | — |
| SECONDARY Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint |
19.13; 17.71 | — |
| SECONDARY Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline |
3.86; 3.72 | — |
| SECONDARY Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint |
5.57; 5.10 | — |
Summary
The aim of the study is to use the antioxidant and antiinflammatory effects of lipoic acid to improve the quality of life of patients with asthma.
The investigators will administrate 600 mg lipoic acid orally on a daily basis during two months concurrent with the patient anti-asthmatic therapy and evaluate the effects on resulting pulmonary function, inflammatory and oxidative stress biomarkers and health-related quality of life previous to the initial of the treatment and at 60 days of the supplementary therapy.
Eligibility Criteria
Inclusion Criteria
- Outpatients (≥18 and ≤ 75 years of age) female or male
- Willingness to participate and comply with procedures by signing a written informed consent
- Moderate/severe persistent allergic rhinitis according to Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines with a history of intermittent, mild persistent or moderate persistent asthma according to GINA guidelines
- Confirmed allergy to at least one of the following allergen preparations: house dust mite f; house dust mite p; cockroach; bush mix; tree mix; grass mix; weed mix, cat; or dog.
- All prior medication washout times had been observed
- Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception
- Negative urine pregnancy test
- Without a concomitant chronic medical condition (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- Willingness to adhere to the dosing and visit schedules
Exclusion Criteria
- Pregnant or breastfeeding
- Female who was or intended to become pregnant during the study or within 12 weeks after study completion
- Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
- Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
- Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
- Upper respiratory tract or sinus infection that required antibiotic therapy and had not had at least a 14-day wash-out period prior to the run-in period
- Patients undergoing a progressive course of immunotherapy. Subjects on a regular maintenance schedule prior to the screening visit are eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
- Concomitant medical problem
- In a situation or condition that could interfere with participation in the study
- Allergic or sensitivity to the study drug or its excipients
- History of inadequate adherence to treatment
Data sourced from ClinicalTrials.gov (NCT01221350). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.