Clinical trial NCT01221350: Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients
Official title: Exploratory Study of Lipoic Acid Supplementation on Oxidative Stress, Inflammatory and Functional Markers in Asthmatic Patients: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Allergic Rhinitis
Keywords: Asthma
Allergic rhinitis
Respiratory disease
Allergy
Lipoic acid
Thioctic acid
Antioxidant
Oxidative stress
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
Collaborators: name: National Council of Science and Technology, Mexico
name: University of Guadalajara
name: Hospital Civil Juan I. Menchaca
First posted: 2010-10-15
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: Asthma is an inflammatory disease of high prevalence around the world. During development of asthma the presence of oxidative stress has been related to susceptibility and severity of the disease, thus making the use of antioxidant adjuvant therapy with lipoic acid (LA) an interesting treatment option. The objective of the study is to evaluate the efficacy of LA as an adjuvant treatment on functional, antioxidant, inflammatory, quality and control parameters of asthma in human subjects. The trial design is a randomized, double blind, placebo controlled parallel study.

Adult patients (\>18 years) with history of mild intermittent to moderate asthma according to the Global Initiative for Asthma (GINA) guidelines were enrolled. It was required a positive skin prick test (\>3 mm) for at least two regional allergens. Patients were randomly assigned to receive lipoic acid or placebo for 60 days. Participants had an intermediate visit to the attending physician one month after initial of treatment to monitor adverse events and to undergo laboratory tests.

1. Introduction. Asthma is an inflammatory disease of high prevalence around the world. During development of asthma the presence of oxidative stress has been related to susceptibility and severity of the disease, thus making the use of antioxidant adjuvant therapy with lipoic acid (LA) an interesting treatment option.
2. Study design. A randomized, double blind, placebo controlled parallel study
3. Methods. Participants and interventions: 55 patients with mild to moderate asthma from Hospital Civil "Juan I. Menchaca" in Guadalajara, Jalisco, México were included and randomized in block of 10 to receive; LA (600 mg/day) or placebo for eight weeks from January to October of 2011.
4. Objective. To evaluate the efficacy of LA as an adjuvant treatment on functional, antioxidant, inflammatory, quality and control parameters of asthma in human subjects. Primary outcome: change on Forced expiratory volume in 1 second (FEV1), secondary outcomes were levels of Oxygen radical absorbance capacity (ORAC), glutathione (GSH), glutathione disulfide (GSSG), protein carbonyls, differential count of sputum cells, interleukin-4 (IL-4) and scores of quality of life and control of asthma questionnaires.

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

Primary outcomes:
measure: Spirometric FVC Values at Baseline
timeFrame: Baseline
measure: Spirometric FVC Values at Endpoint
timeFrame: 60 days
measure: Spirometric FEV1 Values at Baseline
timeFrame: Baseline
measure: Spirometric FEV1 Values at Endpoint
timeFrame: 60 days
measure: Spirometric FEF Values at Baseline
timeFrame: Baseline
measure: Spirometric FEF Values at Endpoint
timeFrame: 60 days
Secondary outcomes:
measure: Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline
timeFrame: Baseline
measure: Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint
timeFrame: 60 days
measure: Induced Sputum Carbonylated Proteins at Baseline
timeFrame: Baseline
measure: Induced Sputum Carbonylated Proteins at Endpoint
timeFrame: 60 days
measure: Induced Sputum Eosinophils at Baseline
timeFrame: Baseline
measure: Induced Sputum Eosinophils at Endpoint
timeFrame: 60 days
measure: Inflammatory Interleukin-4 (IL-4) Sputum Levels at Baseline
timeFrame: Baseline
measure: Inflammatory IL-4 Sputum Levels at Endpoint
timeFrame: 60 days
measure: Measurement of Quality of Life With the ACT (Asthma Control Test) at Baseline
timeFrame: Baseline
measure: Measurement of Quality of Life With the ACT (Asthma Control Test) at Endpoint
timeFrame: 60 days
measure: Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Baseline
timeFrame: Baseline
measure: Measurement of Quality of Life With the AQLQ (Asthma Quality of Life Questionnaire) at Endpoint
timeFrame: 60 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara "Juan I. Menchaca"
state: Jalisco
city: Guadalajara
country: Mexico
facility: Departamento de Fisiología, CUCS, UdeG
state: Jalisco
Study officials:
affiliation: Centro Universitario de Ciencias de la Salud, Mexico
name: Fernando R. Siller Lopez, PhD
role: PRINCIPAL_INVESTIGATOR
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