Efficacy Of Doxophylline As A Sparing Treatment For Inhaled

Status Not yet recruiting

Clinical 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). 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03879590
Study type	Interventional
Source	Universidad Autonoma de Nuevo Leon
Contact	Carlos Macouzet-Sánchez, Dr.
Phone	+528183462515
Email	dr.macouzet@gmail.com
Status	Not yet recruiting
Phase	Phase 3
Start date	May 2019
Completion date	December 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04450108` - Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients	N/A
Recruiting	`NCT05734261` - Forced Oscillations Technique During a Metacholine Test in Children	N/A
Recruiting	`NCT06044051` - Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma	N/A
Completed	`NCT04896502` - Effectiveness of Telemedicine Home Assessments for Identification and Reduction of Asthma Triggers	N/A
Completed	`NCT03503812` - Mitigating the Health Effects of Desert Dust Storms Using Exposure-Reduction Approaches	N/A
Recruiting	`NCT06003569` - Reducing Asthma Attacks in Disadvantaged School Children With Asthma	N/A
Not yet recruiting	`NCT05902702` - Isotonic Saline for Children With Bronchiolitis	N/A
Not yet recruiting	`NCT05547477` - Continuous EMG Measurements in Children With Asthma During Sleep
Completed	`NCT04388098` - Oral Health Status of Asthmatic Children
Terminated	`NCT03586544` - Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity	Phase 4
Recruiting	`NCT04821908` - Consequences of COVID 19 Pandemic on Childhood Asthma
Not yet recruiting	`NCT03277170` - Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations	Phase 2
Enrolling by invitation	`NCT06239844` - Navigating Together for Equitable Asthma Management for Children in Families Who Communicate in Language Other Than English	N/A
Not yet recruiting	`NCT05974917` - Serious gaMes as Emerging E-health Interventions for Young People With neurologicaL or rEspiratory disoRders
Not yet recruiting	`NCT05997784` - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Recruiting	`NCT05366309` - Performance and Adherence in Children Using Spacers	N/A
Completed	`NCT05684926` - COVID-19 Pandemic Asthma Child Telerehabilitation Yoga	N/A
Recruiting	`NCT04166344` - A mHealth Intervention to Improve Symptom Control in Children and Adolescents With Difficult-to-control Asthma	N/A
Completed	`NCT05576142` - Oral Findings in Pediatric Patients With Allergic Rhinitis and/or Asthma
Completed	`NCT03907410` - The Tailored Adherence Incentives for Childhood Asthma Medications (TAICAM) Trial	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms