Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease

NCT06346691 — Phase 4, Completed, 20 participants, Thammasat University

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

Registry	NCT06346691
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	20 (Actual)
Sponsor	Thammasat University (Other)
Conditions	COPD
Interventions	Doxofylline, Procaterol (Drug)
Dates	start 2024-03-01, primary completion 2024-10-31, completion 2024-11-15, first posted 2024-04-04, last updated 2025-01-20
Locations	1 site in Thailand

-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?"

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Doxofylline arm	Experimental	Drug: Doxofylline	Doxofylline 400 mg oral twice daily for 4 weeks
Procaterol arm	Active comparator	Drug: Procaterol	Procaterol 50 mcg oral twice daily for 4 weeks

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.

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: All, ages: 40 Years to any

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

+Locations (1)

Facility	City	Country	Status
Narongkorn Saiphoklang	Klongluang, Changwat Pathum Thani	Thailand

+Investigators

Narongkorn Saiphoklang, MD, Principal investigator, Thammasat University Faculty of Medicine