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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06346691
• Other study ID #: MTU-EC-IM-0-235/66
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?"

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Forced vital capacity (FVC)	Postbronchodilator FVC	At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Primary	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	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
Secondary	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