Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease

Phase 4

Not yet recruiting

• Conditions: COPD
• Interventions: Drug: Doxofylline; Drug: Procaterol

• Registration Number: NCT06346691
• Lead Sponsor: Thammasat University

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.

Study Timeline

• Study First Submitted: 2024-03-28
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-04
• Last Update Posted: 2024-04-05
• Study Start: 2024-04-16
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Doxofylline arm	Doxofylline	Doxofylline 400 mg oral twice daily for 4 weeks
Procaterol arm	Procaterol	Procaterol 50 mcg oral twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second (FEV1)	At the day of randomization (week 0), week 4, week 6, and week 8 of the study	Postbronchodilator FEV1
Forced vital capacity (FVC)	At the day of randomization (week 0), week 4, week 6, and week 8 of the study	Postbronchodilator FVC
Forced expiratory flow at 25-75% of FVC (FEF25-75)	At the day of randomization (week 0), week 4, week 6, and week 8 of the study	Postbronchodilator FEF25-75

Secondary Outcome Measures

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