Clinical trial NCT06346691: Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease
Official title: Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : a Randomized Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: Chronic obstructive pulmonary disease
COPD
Bronchodilator
Doxofylline
Procaterol
Pulmonary function
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Forced expiratory volume in 1 second (FEV1)
timeFrame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
measure: Forced vital capacity (FVC)
timeFrame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
measure: Forced expiratory flow at 25-75% of FVC (FEF25-75)
timeFrame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Secondary outcomes:
measure: modified Medical Research Council (mMRC) score
timeFrame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
measure: COPD Assessment Test (CAT)
timeFrame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Narongkorn Saiphoklang
state: Pathumthani
Study officials:
affiliation: Thammasat University Faculty of Medicine
name: Narongkorn Saiphoklang, MD
role: PRINCIPAL_INVESTIGATOR
References: