COPDPhase 4NCT06346691
Effects of Oral Doxofylline and Procaterol on Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Doxofylline and Procaterol in people with COPD, run by Thammasat University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Doxofylline and Procaterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2024to 15 Nov 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- Aged 40 years or older
- Smoking 10 pack-years or more
- Postbronchodilator FEV1 < 80%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Narongkorn Saiphoklang
Klongluang, Changwat Pathum Thani, 12120
About this study
Official title: Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : a Randomized Crossover Study
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?"
Read the 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.
- Conditions
- COPD
- Being tested
- Doxofylline, Procaterol
- Keywords
- Chronic obstructive pulmonary disease, COPD, Bronchodilator, Doxofylline, Procaterol, Pulmonary function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxofyllineDrug
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.
ProcaterolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Doxofylline arm | Experimental | Doxofylline 400 mg oral twice daily for 4 weeks Receives: Drug: Doxofylline |
| Procaterol arm | Active comparator | Procaterol 50 mcg oral twice daily for 4 weeks Receives: Drug: Procaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory volume in 1 second (FEV1)
Postbronchodilator FEV1
Measured: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Forced vital capacity (FVC)
Postbronchodilator FVC
Measured: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Forced expiratory flow at 25-75% of FVC (FEF25-75)
Postbronchodilator FEF25-75
Measured: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Secondary outcomes (2)
modified Medical Research Council (mMRC) score
Scores range from 0 to 4, with higher scores indicating a worse outcome
Measured: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
COPD Assessment Test (CAT)
Scores range from 0 to 40, with higher scores indicating a worse outcome
Measured: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start1 Mar 2024
- Primary completion31 Oct 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
- Investigators
- Narongkorn Saiphoklang, MD, Principal investigator, Thammasat University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346691
- Sponsor's protocol ID
- MTU-EC-IM-0-235/66
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchodilator Effect of Oral Doxofylline and Procaterol in Chronic Obstructive Pulmonary Disease : a Randomized Crossover Study
- ClinicalTrials.gov ID
- NCT06346691
- Acronym / sponsor ID
- MTU-EC-IM-0-235/66
- Conditions
- COPD
- Keywords
- Chronic obstructive pulmonary disease, COPD, Bronchodilator, Doxofylline, Procaterol, Pulmonary function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Doxofylline arm | Experimental | Drug: DoxofyllineDoxofylline 400 mg oral twice daily for 4 weeks |
| Procaterol arm | Active comparator | Drug: ProcaterolProcaterol 50 mcg oral twice daily for 4 weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- COPD diagnosis confirmed by spirometry (post-bronchodilator FEV1/FVC < 70%)
- Aged 40 years or older
- Smoking 10 pack-years or more
- Postbronchodilator FEV1 < 80%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxofyllineEach 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. | Drug | Doxofylline arm |
| ProcaterolEach 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. | Drug | Procaterol arm |
Primary outcome
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
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
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
2 secondary outcomes
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
COPD Assessment Test (CAT)
Time frame: At the day of randomization (week 0), week 4, week 6, and week 8 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narongkorn Saiphoklang, MD principal investigator
Thammasat University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Doxofylline and Procaterol in people with COPD, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2025.