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Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma

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ClinicalTrials.gov Identifier: NCT03879590
Recruitment Status : Unknown
Verified March 2019 by Sandra Nora Gonzalez Diaz, Universidad Autonoma de Nuevo Leon.
Recruitment status was:  Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Nora Gonzalez Diaz, Universidad Autonoma de Nuevo Leon

Brief Summary:
This study evaluated the efficacy of doxophylline as a steroid sparing treatment in Mexican children with asthma treated with medium ir high doses of inhaled corticosteroids (ICS). It is a cross over study in which both groups of patients will receive doxophylline plus a lower steroid dose maintaining the same treatment step according to GINA guidelines, one group will maintain the same treatment dose while the other will start with doxophylline with the lower ICS dose, and by the middle of the study both groups will interchange treatment schemes.

Condition or disease Intervention/treatment Phase
Asthma Chronic Asthma in Children Drug: Doxophylline Drug: Budesonide Phase 3

Detailed Description:
Inhaled corticosteroids (ICS) are first-line drugs for the treatment of persistent asthma. The effectiveness of existing ICS is excellent; however, a number of questions remain regarding its possible adverse effects, despite the fact that the use of the inhalation route has allowed the minimization of the systemic exposure to these drugs. Methylxanthines are widely used in the treatment of asthma. It is one of the few medications for asthma that can be administered orally. They are useful especially in patients who cannot adapt to inhaled medications. Methylxanthines are unique in exhibiting dual-function properties by inducing bronchodilation and having anti-inflammatory and immunomodulatory effects. Theophylline is the oldest methylxanthine and non-specifically inhibits phosphodiesterase, it is a little used drug because it has many adverse effects with lower therapeutic index. Doxophylline is a drug of the family of methylxanthines, with a similar efficacy compared to theophylline when applied in the treatment of various respiratory diseases, but with better tolerability profile. Doxophylline has been shown to be a bronchodilator and anti-inflammatory drug with a wider therapeutic window than other methylxanthines. Clinical studies have reported that doxophylline is more effective in improving lung function tests in adults and children, as well as in decreasing clinical symptoms, reducing the incidence of adverse effects and the need of emergency bronchodilators, with a better profile in terms of safety and it has been demonstrated that doxophylline potentially reduces the need for corticosteroids.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Of Doxophylline As A Sparing Treatment For Inhaled Corticosteroids In Mexican Children With Asthma
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: Budesonide and Doxophylline
Budesonide at the same dose in which the subject is currently treated (GINA step 3 or 4) plus doxophylline at a dose of 18 mg / kg per day
Drug: Doxophylline
Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
Other Name: There is no other intervention names

Drug: Budesonide
Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
Other Name: There is no other intervention names

Active Comparator: Low budesonide and Doxophylline
Reduced dose of inhaled budesonide (GINA step down) plus doxophylline to a dose of 18 mg / kg per day, maximum of 800 mg / day (Group B)
Drug: Doxophylline
Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
Other Name: There is no other intervention names

Drug: Budesonide
Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
Other Name: There is no other intervention names




Primary Outcome Measures :
  1. Changes in the values of the forced expiratory volume on the first second [ Time Frame: 4 weeks ]
    Changes in the values of FEV1 (FEV1 in percent predicted) by comparing the baseline to subsequent evaluations.


Secondary Outcome Measures :
  1. Use of rescue therapy [ Time Frame: 4 weeks ]
    The use of rescue therapy defined as daily average of inhalations per day according to the data collected in the patient's diaries.

  2. Clinical asthma control assessment [ Time Frame: 4 weeks ]
    Differences in clinical asthma control assessment with a visual analogue scale (minimum score is 1, maximum score is 10,) comparing the baseline to follow-up evaluations.

  3. Asthma exacerbations [ Time Frame: 4 weeks ]
    Number of asthma exacerbations defined as acute episodes of progressively worsening shortness of breath, coughing, wheezing, and chest tightness or any combination thereof for at least 3 days, reported on the patient´s symptoms log.

  4. Use of systemic corticosteroids [ Time Frame: 4 weeks ]
    - The use of systemic corticosteroids for at least 3 days for the treatment of an asthma exacerbation according to the data collected in the patient's diaries.

  5. Changes on the exhaled breath temperature [ Time Frame: 4 weeks ]
    -Differences in values exhaled breath temperature measured in Celsius degrees with the X-halo device, comparing the baseline to follow-up evaluations.



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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Mexican patients between 6 and 16 years old.
  2. Clinical diagnosis of asthma according to the current guidelines of the Global Asthma Initiative (GINA) 2018.
  3. Patients with asthma treated with budesonide at medium or high doses during (GINA guidelines´ steps 3 or 4) at least two months before the first study visit. Budesonide medium dose: 200-400 mcg / day (6-11 years) and 400-800 mcg / day (> 12 years). Budesonide high dose: > 400 mcg / day (6-11 years) and > 800 mcg / day (> 12 years).

Exclusion Criteria:

  1. Patients <6 or ≥16 years of age.
  2. Patients with <16 kg of body weight.
  3. Patients who have had an asthma exacerbation that required treatment with systemic corticosteroids (oral, intramuscular or intravenous) during the 2 months prior to the first study visit.
  4. Patients who have presented an asthma exacerbation that required hospitalization during the 2 months prior to the first study visit.
  5. Any other chronic lung disease that could impair lung function evaluation.
  6. Cardiovascular, infectious, metabolic or neoplastic disease that could interfere with the evaluation of the patient.
  7. Current use of drugs that interact with doxophylline: other xanthines, ephedrine or other sympathomimetics, erythromycin, troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, two months prior vaccination, propranolol, phenytoin or other anticonvulsants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03879590


Contacts
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Contact: Carlos Macouzet-Sánchez, Dr. +528183462515 dr.macouzet@gmail.com

Sponsors and Collaborators
Universidad Autonoma de Nuevo Leon
Investigators
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Principal Investigator: Sandra Nora González-Díaz, PhD Universidad Autónoma de Nuevo León
  Study Documents (Full-Text)

Documents provided by Sandra Nora Gonzalez Diaz, Universidad Autonoma de Nuevo Leon:
Publications of Results:
Other Publications:
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Responsible Party: Sandra Nora Gonzalez Diaz, Dra. med., Universidad Autonoma de Nuevo Leon
ClinicalTrials.gov Identifier: NCT03879590    
Other Study ID Numbers: DOXO
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sandra Nora Gonzalez Diaz, Universidad Autonoma de Nuevo Leon:
doxophylline
asthma
steroid sparing
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Doxofylline
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antitussive Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action