Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

NCT ID: NCT06346691

Last Updated: 2025-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-11-15

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?"

Detailed Description

This study is a randomized crossover study. COPD patients aged 40 years or older with stable disease were included. 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. Respiratory symptoms were assessed by modified Medical Research Council (mMRC) dyspnea scale and COPD Assessment Test (CAT). Pulmonary functions were assessed by spirometry with bronchodilator testing, and adverse events were recorded. Spirometry data including forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and forced expiratory flow at 25-75% of FVC (FEF25-75) were also collected.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxofylline arm

Doxofylline 400 mg oral twice daily for 4 weeks

Group Type: EXPERIMENTAL

Doxofylline

Intervention Type: 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

Procaterol 50 mcg oral twice daily for 4 weeks

Group Type: ACTIVE_COMPARATOR

Procaterol

Intervention Type: 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.

Interventions

Doxofylline

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.

Intervention Type: DRUG

Procaterol

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

Narongkorn Saiphoklang, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Narongkorn Saiphoklang, MD

Role: PRINCIPAL_INVESTIGATOR

Thammasat University Faculty of Medicine

Locations

Narongkorn Saiphoklang

Klongluang, Changwat Pathum Thani, Thailand

Countries

Thailand

Other Identifiers

MTU-EC-IM-0-235/66

Identifier Type: -

Identifier Source: org_study_id