Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : a Randomized Crossover Study

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?"

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Drug: Doxofylline; Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Pathumthani
    • Klongluang, Pathumthani, Thailand, 12120
      • Narongkorn Saiphoklang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Doxofylline arm; Doxofylline 400 mg oral twice daily for 4 weeks	Drug: 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.
Active Comparator: Procaterol arm; Procaterol 50 mcg oral twice daily for 4 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
modified Medical Research Council (mMRC) score	Scores range from 0 to 4, with higher scores indicating a worse outcome	At the day of randomization (week 0), week 4, week 6, and week 8 of the study
COPD Assessment Test (CAT)	Scores range from 0 to 40, with higher scores indicating a worse outcome	At the day of randomization (week 0), week 4, week 6, and week 8 of the study

Collaborators and Investigators

• Sponsor: Thammasat University
• Investigators: Principal Investigator: Narongkorn Saiphoklang, MD, Thammasat University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): November 15, 2024

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease; Pulmonary function; Bronchodilator; Doxofylline; Procaterol
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Phosphodiesterase Inhibitors; Sympathomimetics; Antitussive Agents; Doxofylline; Procaterol
• Other Study ID Numbers: MTU-EC-IM-0-235/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• 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