Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients With Allergic Rhinitis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Centro Universitario de Ciencias de la Salud, Mexico.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Centro Universitario de Ciencias de la Salud, Mexico
Collaborators:
Hospital Civil Juan I. Menchaca
National Council of Science and Technology, Mexico
Information provided by:
Centro Universitario de Ciencias de la Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01221350
First received: October 14, 2010
Last updated: June 22, 2011
Last verified: February 2011
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Purpose
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 and allergic rhinitis.
The investigators will administrate 600 mg lipoic acid 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 one and two months of the supplementary therapy.
| Condition | Intervention |
|---|---|
|
Asthma Allergic Rhinitis |
Dietary Supplement: Lipoic acid Dietary Supplement: Placebo capsule |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Supportive Care |
| Official Title: | Exploratory Study of Lipoic Acid Supplementation on Oxidative Stress, Inflammatory and Functional Markers in Asthmatic Patients With Allergic Rhinitis: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial. |
Resource links provided by NLM:
Further study details as provided by Centro Universitario de Ciencias de la Salud, Mexico:
Primary Outcome Measures:
- The change in spirometric FEV1 values, antioxidant capacity and inflammatory parameters from baseline to endpoint after 60 days of lipoic acid treatment [ Time Frame: 60 days ] [ Designated as safety issue: No ]Measurement of spirometry parameters, sputum levels of IL-4, differential cell counting of cytospin preparations, GSH and GSSG levels, 8-isoprostanes and ORAC values at the baseline and after 60 days of treatment
Secondary Outcome Measures:
- Measurement of Quality of Life at baseline and after 60 days of treatment [ Time Frame: 60 days ] [ Designated as safety issue: No ]Assessment of Quality of life scores with the AQLQ and RQLQ packages.
| Estimated Enrollment: | 60 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lipoic acid 600 mg capsule
Lipoic acid 600 mg capsule once daily in the morning
|
Dietary Supplement: Lipoic acid
Lipoic acid 600 mg capsule once daily in the morning
Other Names:
|
|
Placebo Comparator: Placebo capsule
Placebo 600 mg once daily in the morning
|
Dietary Supplement: Placebo capsule
Placebo 600 mg once daily in the morning
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01221350
Contacts
| Contact: Fernando R. Siller-Lopez, Ph.D. | 5233 1058-5200 ext 33723 | fsiller@cucs.udg.mx |
| Contact: Gabriela Vazquez-Armenta, M.D. | 33 1417-1824 | gaby.vazar@gmail.com |
Locations
| Mexico | |
| Instituto de Oftalmología y Ciencias Visuales, CUCS, UdeG | Recruiting |
| Guadalajara, Jalisco, Mexico, 44348 | |
| Contact: Fernando Siller Lopez, PhD 5233 1058-5200 ext 3723 fsiller@cucs.udg.mx | |
| Contact: Gabriela Vazquez Armenta, MD gaby.vazar@gmail.com | |
| Hospital Civil de Guadalajara "Juan I. Menchaca" | Recruiting |
| Guadalajara, Jalisco, Mexico, 44340 | |
| Contact: Gabriela Vazquez-Armenta, M.D. 33 1417-1824 gaby.vazquez@live.com | |
| Contact: Fernando Moreno-Avila, M.D. 33 3617-0067 fmoreno@hotmail.com | |
Sponsors and Collaborators
Centro Universitario de Ciencias de la Salud, Mexico
Hospital Civil Juan I. Menchaca
National Council of Science and Technology, Mexico
Investigators
| Principal Investigator: | Fernando R. Siller Lopez, PhD | Centro Universitario de Ciencias de la Salud, Mexico |
More Information
Additional Information:
Publications:
| Responsible Party: | Dr. Fernando Rafael Siller López, Universidad de Guadalajara |
| ClinicalTrials.gov Identifier: | NCT01221350 History of Changes |
| Other Study ID Numbers: | UdeG-FSL-2010, Salud-2010-C01-140590 |
| Study First Received: | October 14, 2010 |
| Last Updated: | June 22, 2011 |
| Health Authority: | Mexico: National Council of Science and Technology Mexico: Secretaria de Salud |
Keywords provided by Centro Universitario de Ciencias de la Salud, Mexico:
|
Asthma Allergic rhinitis Lipoic acid Antioxidants |
Oxidative stress Respiratory disease Allergy |
Additional relevant MeSH terms:
|
Asthma Rhinitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Nose Diseases Respiratory Tract Infections |
Otorhinolaryngologic Diseases Thioctic Acid Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 16, 2013