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Asthma ChronicPhase 3NCT03879590

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

A Phase 3 study testing Doxophylline and Budesonide in people with Asthma Chronic and Asthma in Children, run by Universidad Autonoma de Nuevo Leon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Asthma Chronic, Asthma in Children
What is being tested?
Doxophylline and Budesonide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
May 2019to Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Mexican patients between 6 and 16 years old.
  • Clinical diagnosis of asthma according to the current guidelines of the Global Asthma Initiative (GINA) 2018.
  • 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).

Who cannot join

  • Patients <6 or ≥16 years of age.
  • Patients with <16 kg of body weight.
  • 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.
  • Patients who have presented an asthma exacerbation that required hospitalization during the 2 months prior to the first study visit.
  • Any other chronic lung disease that could impair lung function evaluation.
  • Cardiovascular, infectious, metabolic or neoplastic disease that could interfere with the evaluation of the patient.
  • 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.

Trial locations and contacts

No sites are listed yet.

Carlos Macouzet-Sánchez, Dr. contact

+528183462515

dr.macouzet@gmail.com

About this study

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.

Read the 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.

Being tested
Doxophylline, Budesonide
Keywords
doxophylline, asthma, steroid sparing
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DoxophyllineDrug

    Also called There is no other intervention names

    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.

  • BudesonideDrug

    Also called There is no other intervention names

    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.

Study groups in NCT03879590
Study groupRoleWhat they receive
Budesonide and DoxophyllineExperimentalBudesonide 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
Receives: Drug: Doxophylline; Drug: Budesonide
Low budesonide and DoxophyllineActive comparatorReduced 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)
Receives: Drug: Doxophylline; Drug: Budesonide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in the values of the forced expiratory volume on the first second

    Changes in the values of FEV1 (FEV1 in percent predicted) by comparing the baseline to subsequent evaluations.

    Measured: 4 weeks

Secondary outcomes (5)

  1. Use of rescue therapy

    The use of rescue therapy defined as daily average of inhalations per day according to the data collected in the patient's diaries.

    Measured: 4 weeks

  2. Clinical asthma control assessment

    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.

    Measured: 4 weeks

  3. Asthma exacerbations

    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.

    Measured: 4 weeks

  4. Use of systemic corticosteroids

    • 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.

    Measured: 4 weeks

  5. Changes on the exhaled breath temperature

    -Differences in values exhaled breath temperature measured in Celsius degrees with the X-halo device, comparing the baseline to follow-up evaluations.

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study startMay 2019 (estimated)
  3. Primary completionSep 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03879590
Sponsor's protocol ID
DOXO
Status last verified
Mar 2019
First submitted
25 Nov 2018
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lal D, Manocha S, Ray A, Vijayan VK, Kumar R. Comparative study of the efficacy and safety of theophylline and doxofylline in patients with bronchial asthma and chronic obstructive pulmonary disease. J Basic Clin Physiol Pharmacol. 2015 Sep;26(5):443-51. doi: 10.1515/jbcpp-2015-0006.

    PubMed 25894641

  • Margay SM, Farhat S, Kaur S, Teli HA. To study the efficacy and safety of doxophylline and theophylline in bronchial asthma. J Clin Diagn Res. 2015 Apr;9(4):FC05-8. doi: 10.7860/JCDR/2015/12438.5743. Epub 2015 Apr 1.

    PubMed 26023566

  • Rajanandh MG, Nageswari AD, Ilango K. Assessment of various second-line medications in addition to inhaled corticosteroid in asthma patients: a randomized controlled trial. Clin Exp Pharmacol Physiol. 2014 Jul;41(7):509-13. doi: 10.1111/1440-1681.12239.

    PubMed 24738981

  • Riffo-Vasquez Y, Venkatasamy R, Page CP. Steroid sparing effects of doxofylline. Pulm Pharmacol Ther. 2018 Feb;48:1-4. doi: 10.1016/j.pupt.2017.10.008. Epub 2017 Oct 16.

    PubMed 29031617

  • Rajanandh MG, Nageswari AD, Ilango K. Pulmonary function assessment in mild to moderate persistent asthma patients receiving montelukast, doxofylline, and tiotropium with budesonide: a randomized controlled study. Clin Ther. 2014 Apr 1;36(4):526-33. doi: 10.1016/j.clinthera.2014.02.006. Epub 2014 Mar 17.

    PubMed 24650447

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Doxophylline and Budesonide in people with Asthma Chronic and Asthma in Children, run by Universidad Autonoma de Nuevo Leon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Carlos Macouzet-Sánchez, Dr. (+528183462515, dr.macouzet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the values of the forced expiratory volume on the first second (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03879590, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

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