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OpenTrials
Completed

NCT Number: NCT06346691

Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

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?"

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Narongkorn Saiphoklang

Klongluang, Changwat Pathum Thani, 12120, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Forced expiratory volume in 1 second (FEV1)

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

    Postbronchodilator FEV1

  2. Forced vital capacity (FVC)

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

    Postbronchodilator FVC

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

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

    Postbronchodilator FEF25-75

Secondary outcomes

  1. modified Medical Research Council (mMRC) score

    Time frame: 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

  2. COPD Assessment Test (CAT)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Thammasat University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 4, 2024
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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