Trials / Completed
CompletedNCT03388853
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe COPD.
Efficacy and Safety Study of Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet in the Treatment of Moderate-Severe Chronic Obstructive Pulmonary Disease (COPD)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Neutec Ar-Ge San ve Tic A.Ş · Industry
- Sex
- All
- Age
- 40 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Acetylcysteine/Doxofylline | Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks. |
| OTHER | Placebo | Placebo once daily for four weeks. |
Timeline
- Start date
- 2018-02-20
- Primary completion
- 2019-12-21
- Completion
- 2019-12-21
- First posted
- 2018-01-03
- Last updated
- 2020-06-12
Locations
2 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT03388853. Inclusion in this directory is not an endorsement.