COPDPhase 4NCT03388853
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.
A Phase 4 study testing Acetylcysteine/Doxofylline in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites in Turkey (Türkiye).
Trial summary
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Acetylcysteine/Doxofylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Feb 2018to 21 Dec 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD and on a therapeutic regimen for COPD for a year
- Patients with post-bronchodilator FEV1/FVC ratio <0.70
- Patients with post-bronchodilator FEV1≥30% and <80% of predicted normal value.
- Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- Patients who have no exacerbation within last 4 weeks
- Females patients with childbearing potential using effective birth control method
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- Patients who have a capability of communicate with investigator
- Patients who accept to comply with the requirements of the protocol
- Patients who signed written informed consent prior to participation
Who cannot join
- History of hypersensitivity to drugs contain Acetylcysteine or Doxofylline or other mucolitics or xanthines
- Patients who use mucolitic and/or xantines derivatives or ephedrine routinely.
- Patients who use CPAP (continous positive airway measure), BiPAP (bilevel continous positive airway measure) or mechanical ventilation
- History of chronic respiratory diseases except COPD.
- Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to first visit.
- Patients who have a history of myocardial infarction, hearth failure, acute ischemic coroner disease or severe cardiac arrhythmia requiring treatment within least 6 weeks.
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- History of significant or uncontrolled disease or operation that may preclude participant from participating in the study
- Patients who have lung cancer
- Patients who had lung volume reduction operation
- Women patients who are pregnant or nursing
- History of allergic rhinitis or atopy
- Patients who have known serious prostatic hypertrophy or narrow-angle glaucoma requiring drug therapy
- History of alcohol abuse.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Cukurova University Faculty of Medicine, Chest Diseases Department
Adana
Health Sciences University, Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD)
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
Read the detailed description
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
Patients who met all inclusion criteria will be randomized to receive double-blind treatment with Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily (n = 35) or placebo (n = 35) once daily for 4 weeks.
Patients will be evaluated at 2 consecutive visits: screening \& treatment visit (first visit) and after treatment visit (second visit).
Spirometric measurements will be performed at pre-treatment during the first visit and post-treatment at two different time points (23 hr + 15 min and 23 hr + 45 min) during the second visit. The average of the values at 23 hr 15 min and 23 hr 45 min during the second visit will be defined as trough value.
- Conditions
- COPD
- Being tested
- Acetylcysteine/Doxofylline, Placebo
- Keywords
- Acetylcysteine/Doxofylline, Acetylcysteine, Doxofylline, Effervescent Tablet, COPD
- 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.
Acetylcysteine/DoxofyllineDrug
Also called Mucofix 1200/400 mg Effervescent Tablet
Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
PlaceboOther
Placebo once daily for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Acetylcysteine/Doxofylline | Experimental | Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. Receives: Drug: Acetylcysteine/Doxofylline |
| Placebo | Placebo comparator | Placebo once daily for four weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
Measured: 4 weeks
Secondary outcomes (6)
Mean changes in Clinical COPD Questionnaire (CCQ) score from baseline
Measured: 4 weeks
Mean changes in Modified Medical Research Council dyspnea scale (mMRC) from baseline
Measured: 4 weeks
Mean changes in FEV1 from baseline
Measured: 4 weeks
Mean changes in FVC from baseline
Measured: 4 weeks
Mean changes in serum C-reactive protein (CRP) concentration from baseline
Measured: 4 weeks
Evaluation of safety of study drug
Number of participants with treatment-related adverse events and/or abnormal laboratory values.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start20 Feb 2018
- Primary completion21 Dec 2019
- Study completion21 Dec 2019
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388853
- Sponsor's protocol ID
- NEU-06.15
- Status last verified
- Dec 2017
- First submitted
- 12 Dec 2017
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03388853
- Acronym / sponsor ID
- NEU-06.15
- Conditions
- COPD
- Keywords
- Acetylcysteine/Doxofylline, Acetylcysteine, Doxofylline, Effervescent Tablet, COPD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 21 Dec 2019 (actual)
- Study completion
- 21 Dec 2019 (actual)
- First posted
- 3 Jan 2018 (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 objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
Detailed description
The objective is to assess efficacy and safety of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily treatment besides standard/usual treatment, as compared with placebo once daily in patients with stable moderate to severe COPD.
Patients who met all inclusion criteria will be randomized to receive double-blind treatment with Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily (n = 35) or placebo (n = 35) once daily for 4 weeks.
Patients will be evaluated at 2 consecutive visits: screening \& treatment visit (first visit) and after treatment visit (second visit).
Spirometric measurements will be performed at pre-treatment during the first visit and post-treatment at two different time points (23 hr + 15 min and 23 hr + 45 min) during the second visit. The average of the values at 23 hr 15 min and 23 hr 45 min during the second visit will be defined as trough value.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetylcysteine/Doxofylline | Experimental | Drug: Acetylcysteine/DoxofyllineAcetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo once daily for four weeks |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥40 years with moderate-severe COPD diagnosis according to the GOLD and on a therapeutic regimen for COPD for a year
- Patients with post-bronchodilator FEV1/FVC ratio <0.70
- Patients with post-bronchodilator FEV1≥30% and <80% of predicted normal value.
- Current smokers or ex-smokers with a smoking history of at least 10 pack-years
- Patients who have no exacerbation within last 4 weeks
Key exclusion criteria (13 listed)
- History of hypersensitivity to drugs contain Acetylcysteine or Doxofylline or other mucolitics or xanthines
- Patients who use mucolitic and/or xantines derivatives or ephedrine routinely.
- Patients who use CPAP (continous positive airway measure), BiPAP (bilevel continous positive airway measure) or mechanical ventilation
- History of chronic respiratory diseases except COPD.
- Patients who had COPD exacerbation or lower respiratory track infections that required antibiotic, oral or parenteral corticosteroid treatment within 4 weeks prior to first visit.
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 |
|---|---|---|
| Acetylcysteine/DoxofyllineAlso: Mucofix 1200/400 mg Effervescent TabletAcetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. | Drug | Acetylcysteine/Doxofylline |
| PlaceboPlacebo once daily for four weeks. | Other | Placebo |
Primary outcome
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
Time frame: 4 weeks
6 secondary outcomes
Mean changes in Clinical COPD Questionnaire (CCQ) score from baseline
Time frame: 4 weeks
Mean changes in Modified Medical Research Council dyspnea scale (mMRC) from baseline
Time frame: 4 weeks
Mean changes in FEV1 from baseline
Time frame: 4 weeks
Mean changes in FVC from baseline
Time frame: 4 weeks
Mean changes in serum C-reactive protein (CRP) concentration from baseline
Time frame: 4 weeks
Evaluation of safety of study drug
Time frame: 4 weeks
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 12 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetylcysteine/Doxofylline in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 2 sites in Turkey (Türkiye).
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 9 inclusion and 13 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline (time frame: 4 weeks). 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 12 Jun 2020.