A Phase 4 interventional study of Acetylcysteine/Doxofylline and Placebo in COPD, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Completed at 2 sites in Turkey. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-06-12.
Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 4, Interventional, and Treatment
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Among 10 studies testing acetylcysteine in Pulmonary Disease, Chronic Obstructive — 2 open to participants now, 2 under way, 1 of them phase 3. Acetylcysteine · Pulmonary Disease, Chronic Obstructive.
Among the 10 studies testing acetylcysteine in Pulmonary Disease, Chronic Obstructive, this one is the 5th largest by enrollment, is the only one that started in 2018, is one of 3 in phase 4, and was the 7th registered.
5,521 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →2 of the 10 studies testing acetylcysteine in Pulmonary Disease, Chronic Obstructive are open now, in 2 countries. Recruiting first, the newest first:
National University of Malaysia · Sites in Malaysia
Ages 40+
Queen Mary Hospital, Hong Kong · Sites in Hong Kong
Ages 40+
By country, each count listing its studies:
Acetylcysteine: first FDA approval 1963 (MUCOMYST). What it is approved for, and how studies give it, is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 68 is close to the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 58 across the 10 interventional studies. Of the 7 that completed or were terminated, 3 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 10 have an industry lead sponsor. The 10 most frequent:
Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Neutec Ar-Ge San ve Tic A.Ş has 9 studies filed under Pulmonary Disease, Chronic Obstructive — fewer than ten, so there is no comparison to draw.
1 of the studies testing acetylcysteine in Pulmonary Disease, Chronic Obstructive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06377410National University of MalaysiaEfficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients | 2026-11-30 |
Add it to your calendar (.ics) → With an account.
Among the 10 studies testing acetylcysteine in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
Drug: Acetylcysteine/Doxofylline
Placebo once daily for four weeks
Other: Placebo
Drug pages: Acetylcysteine · Doxofylline
Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
Also known as: Mucofix 1200/400 mg Effervescent Tablet
Placebo once daily for four weeks.
Mean changes in Breathlessness, Cough, and Sputum Scale (BCSS) score from baseline
Time frame: 4 weeks
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
Number of participants with treatment-related adverse events and/or abnormal laboratory values.
Time frame: 4 weeks
Ran from Feb 2018 to primary completion in Dec 2019, 22 months.
Of 71 industry-sponsored phase 4 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 22. This study's 22 months is above that.
Counting every sponsor, half of 157 studies reached it within 19 months; a quarter within 12 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Acetylcysteine · Doxofylline
Pulmonary Disease, Chronic Obstructive →
Neutec Ar-Ge San ve Tic A.Ş