Effects of Lipoic Acid on Oxidative, Inflammatory and Functional Markers in Asthmatic Patients

NCT01221350 | Completed Results

• 2 other identifiers: UdeG-FSL-2010Salud-2010-C01-140590
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma; Allergic Rhinitis

Keywords

Asthma; Allergic rhinitis; Respiratory disease; Allergy; Lipoic acid; Thioctic acid; Antioxidant; Oxidative stress

Outcome Measures

Primary Outcomes (6)

• Spirometric FVC Values at Baseline

  Measurement of spirometric predicted parameters at baseline. Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.

  Baseline

• Spirometric FVC Values at Endpoint

  Measurement of spirometric predicted parameters at the baseline and after 60 days of treatment: Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, measured in liters.

  60 days

• Spirometric FEV1 Values at Baseline

  Measurement of spirometric predicted parameters at baseline: Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.

  Baseline

• Spirometric FEV1 Values at Endpoint

  Measurement of spirometric predicted parameters after 60 days of treatment. Forced expiratory volume in 1 second (FEV1), volume that has been exhaled at the end of the first second of forced expiration.

  60 days

• Spirometric FEF Values at Baseline

  Measurement of spirometric parameters at baseline: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.

  Baseline

• Spirometric FEF Values at Endpoint

  Measurement of spirometric FEF after 60 days of treatment: Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration.

  60 days

Secondary Outcomes (12)

• Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Baseline

  Baseline

• Induced Sputum of Glutathione (GSH)/Glutathione Disulfide (GSSG) Ratio at Endpoint

  60 days

• Induced Sputum Carbonylated Proteins at Baseline

  Baseline

• Induced Sputum Carbonylated Proteins at Endpoint

  60 days

• Induced Sputum Eosinophils at Baseline

  Baseline

Study Arms (2)

Lipoic acid

EXPERIMENTAL

Lipoic acid 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days

Dietary Supplement: Lipoic acid

Placebo

PLACEBO COMPARATOR

Placebo (two placebo capsules) orally once daily in the morning during 60 days

Dietary Supplement: Placebo

Interventions

Lipoic acid DIETARY_SUPPLEMENT

Lipoic acid 600 mg dose (two 300 mg capsules) once daily in the morning. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed.

Also known as: Thioctic Acid, Alpha-Lipoic Acid

Lipoic acid

Placebo DIETARY_SUPPLEMENT

Placebo (two capsules filled with 300 mg vehicle) once daily in the morning during 60 days. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed

Also known as: Placebos, Placebo effect

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centro Universitario de Ciencias de la Salud, Mexico: lead
• National Council of Science and Technology, Mexico: collaborator
• University of Guadalajara: collaborator
• Hospital Civil Juan I. Menchaca: collaborator

Study Sites (2)

Hospital Civil de Guadalajara "Juan I. Menchaca"

Guadalajara, Jalisco, 44340, Mexico

Location

Departamento de Fisiología, CUCS, UdeG

Guadalajara, Jalisco, 44348, Mexico

Location

Related Publications (14)

• Kroegel C. [Global Initiative for Asthma Management and Prevention--GINA 2006]. Pneumologie. 2007 May;61(5):295-304. doi: 10.1055/s-2007-959180. German.

  PMID: 17523070 BACKGROUND

• Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.

  PMID: 20816182 BACKGROUND

• Cho YS, Lee J, Lee TH, Lee EY, Lee KU, Park JY, Moon HB. alpha-Lipoic acid inhibits airway inflammation and hyperresponsiveness in a mouse model of asthma. J Allergy Clin Immunol. 2004 Aug;114(2):429-35. doi: 10.1016/j.jaci.2004.04.004.

  PMID: 15316528 BACKGROUND

• Lee KS, Kim SR, Park SJ, Min KH, Lee KY, Jin SM, Yoo WH, Lee YC. Antioxidant down-regulates interleukin-18 expression in asthma. Mol Pharmacol. 2006 Oct;70(4):1184-93. doi: 10.1124/mol.106.024737. Epub 2006 Jul 5.

  PMID: 16822930 BACKGROUND

• Patel BD, Welch AA, Bingham SA, Luben RN, Day NE, Khaw KT, Lomas DA, Wareham NJ. Dietary antioxidants and asthma in adults. Thorax. 2006 May;61(5):388-93. doi: 10.1136/thx.2004.024935. Epub 2006 Feb 7.

  PMID: 16467075 BACKGROUND

• Miller AL. The etiologies, pathophysiology, and alternative/complementary treatment of asthma. Altern Med Rev. 2001 Feb;6(1):20-47.

  PMID: 11207455 BACKGROUND

• Rahman I. Oxidative stress, chromatin remodeling and gene transcription in inflammation and chronic lung diseases. J Biochem Mol Biol. 2003 Jan 31;36(1):95-109. doi: 10.5483/bmbrep.2003.36.1.095.

  PMID: 12542980 BACKGROUND

• Biewenga GP, Haenen GR, Bast A. The pharmacology of the antioxidant lipoic acid. Gen Pharmacol. 1997 Sep;29(3):315-31. doi: 10.1016/s0306-3623(96)00474-0.

  PMID: 9378235 BACKGROUND

• Singh U, Jialal I. Alpha-lipoic acid supplementation and diabetes. Nutr Rev. 2008 Nov;66(11):646-57. doi: 10.1111/j.1753-4887.2008.00118.x.

  PMID: 19019027 BACKGROUND

• Juniper EF, Guyatt GH, Epstein RS, Ferrie PJ, Jaeschke R, Hiller TK. Evaluation of impairment of health related quality of life in asthma: development of a questionnaire for use in clinical trials. Thorax. 1992 Feb;47(2):76-83. doi: 10.1136/thx.47.2.76.

  PMID: 1549827 BACKGROUND

• Schatz M, Sorkness CA, Li JT, Marcus P, Murray JJ, Nathan RA, Kosinski M, Pendergraft TB, Jhingran P. Asthma Control Test: reliability, validity, and responsiveness in patients not previously followed by asthma specialists. J Allergy Clin Immunol. 2006 Mar;117(3):549-56. doi: 10.1016/j.jaci.2006.01.011.

  PMID: 16522452 BACKGROUND

• Riedl MA, Saxon A, Diaz-Sanchez D. Oral sulforaphane increases Phase II antioxidant enzymes in the human upper airway. Clin Immunol. 2009 Mar;130(3):244-51. doi: 10.1016/j.clim.2008.10.007. Epub 2008 Nov 22.

  PMID: 19028145 BACKGROUND

• Comhair SA, Erzurum SC. Redox control of asthma: molecular mechanisms and therapeutic opportunities. Antioxid Redox Signal. 2010 Jan;12(1):93-124. doi: 10.1089/ars.2008.2425.

  PMID: 19634987 BACKGROUND

• Shay KP, Moreau RF, Smith EJ, Smith AR, Hagen TM. Alpha-lipoic acid as a dietary supplement: molecular mechanisms and therapeutic potential. Biochim Biophys Acta. 2009 Oct;1790(10):1149-60. doi: 10.1016/j.bbagen.2009.07.026. Epub 2009 Aug 4.

  PMID: 19664690 BACKGROUND

Related Links

• Health Sciences Center, University of Guadalajara
• Hospital Civil de Guadalajara

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic; Respiration Disorders; Hypersensitivity

Interventions

Thioctic Acid; Placebo Effect

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids; Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Fernando R Siller Lopez, Ph.D.
• Organization: Centro Universitario de Ciencias de la Salud, Mexico

fsiller@cucs.udg.mx

523310585200

Study Officials

• Fernando R. Siller Lopez, PhD

  Centro Universitario de Ciencias de la Salud, Mexico

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 15, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 8, 2013
• Results First Posted: July 30, 2013

Record last verified: 2013-10

Locations

ME (2)