Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

NCT06346691 | Completed Phase 4

• 1 other identifier: MTU-EC-IM-0-235/66
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to determine if doxofylline and procaterol are effective in treating patients with stable chronic obstructive pulmonary disease (COPD). It will also assess the safety of both drugs. The main questions it aims to answer are:

• Does doxofylline demonstrate a comparable bronchodilator effect to procaterol in COPD participants?
• What medical problems do participants experience when taking doxofylline and procaterol?"

Conditions

COPD

Keywords

Chronic obstructive pulmonary disease; COPD; Bronchodilator; Doxofylline; Procaterol; Pulmonary function

Outcome Measures

Primary Outcomes (3)

• Forced expiratory volume in 1 second (FEV1)

  Postbronchodilator FEV1

  At the day of randomization (week 0), week 4, week 6, and week 8 of the study

• Forced vital capacity (FVC)

  Postbronchodilator FVC

  At the day of randomization (week 0), week 4, week 6, and week 8 of the study

• Forced expiratory flow at 25-75% of FVC (FEF25-75)

  Postbronchodilator FEF25-75

  At the day of randomization (week 0), week 4, week 6, and week 8 of the study

Secondary Outcomes (2)

• modified Medical Research Council (mMRC) score

  At the day of randomization (week 0), week 4, week 6, and week 8 of the study

• COPD Assessment Test (CAT)

  At the day of randomization (week 0), week 4, week 6, and week 8 of the study

Study Arms (2)

Doxofylline arm

EXPERIMENTAL

Doxofylline 400 mg oral twice daily for 4 weeks

Drug: Doxofylline

Procaterol arm

ACTIVE COMPARATOR

Procaterol 50 mcg oral twice daily for 4 weeks

Drug: Procaterol

Interventions

Doxofylline DRUG

Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug.

Doxofylline arm

Procaterol DRUG

Each patient received 4 weeks of treatment with either doxofylline or procaterol followed by a 2-week washout period, and then 4 weeks of treatment with the other drug.

Procaterol arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC \< 70%)
• Aged 40 years or older
• Smoking 10 pack-years or more
• Postbronchodilator FEV1 \< 80%

You may not qualify if:

• History of COPD exacerbation within 3 months
• Oral or intravenous corticosteroid treatment within 6 weeks
• Oral bronchodilators e.g. doxofylline, theophylline, procaterol, or salbutamol within 1 week before randomization
• Asthma
• Tracheostomy, invasive or noninvasive mechanical ventilation
• Inability to perform spirometry or 6-minute walk test
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Thammasat University: lead

Study Sites (1)

Narongkorn Saiphoklang

Klongluang, Changwat Pathum Thani, 12120, Thailand

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

doxofylline; Procaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Narongkorn Saiphoklang, MD

  Thammasat University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Crossover randomized controlled trial

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 4, 2024
• Study Start: March 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: November 15, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

TH (1)