Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2017-000735-14-PL
EUCTR2017-000735-14-PL
Active, not recruiting
Phase 1

The efficacy and safety of new formulation of combination of fluticasone propionate / salmeterol (125µg / 25µg) in MDI HFA inhaler compared with the reference drug at a dose of 500µg / 50µg in DPI (dry powder inhaler) type disc in patients with chronic asthma - COMBO-Study

ek-Am Sp. z o.o.0 sites231 target enrollmentOctober 20, 2017
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsCOMBOTEROLSeretide Disc 500 fluticasone propionate/salmeterol (500µg / 50µg) in DPI device

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ek-Am Sp. z o.o.
Enrollment
231
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 20, 2017
End Date
February 27, 2020
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ek-Am Sp. z o.o.

Eligibility Criteria

Inclusion Criteria

  • •1\. Male and female, age 18\-70
  • •2\. Asthma diagnosed min 3 months before the screening visit. Therapy minimal requirement \- GINA grade 4
  • •3\. FEV1 elevation by at least 12% and min. 200 ml after 400 µg of salbutamol application noted at the screening
  • •4\. FEV1 50\-85% of predicted at the screening visit.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 160
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 60

Exclusion Criteria

  • •1\. Severe life threatening asthma or hospitalisation due to asthma exacerbation during 3 months before the screening
  • •2\. Uncontrolled or untreated significant immunology, endocrinology, hematology, psychiatric, neurology, hepatic, gastrointestinal disorders or neoplasma
  • •3\. Heart arythmia or other cardiovascular disorders, including hypertension with DBP \= 95 mm Hg
  • •4\. Antibiotics taken during last 8 weeks before screening due to respiratory infection
  • •5\. Smoking \>10 cigarettes/day

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A safety and efficacy study of a novel formulation of prednisolone metasulfobenzoate (predocol) in the induction of remission and maintenance in patients with ulcerative colitisAcute exacerbations of ulcerative colitisNutritional, Metabolic, EndocrineUlcerative colitis
ISRCTN14133410Flexpharm Ltd. (UK)180
Recruiting
Phase 2
A Comparative study of efficacy and safety of combination treatment with oral minocycline and narrowband UV-B phototherapy versus narrowband UV-B alone in generalized vitiligogeneralized vitiligovitiligominocyclinePhototherapy
TCTR20210311002Srinakharinwirot University44
Active, not recruiting
Not Applicable
Efficacy and tolerability of a new topical formulation of Acyclovir gel (Acyclorir Liquipatch) given 3 times/day in the treatment of herpes simplex labialis. An open-label, blind controlled, randomised, multicenter, controlled clinical trial versus active reference formulation (Acyclovir 5% cream) given 5 times/day. A superiority trial. - ND
EUCTR2008-005835-14-ITMIPHARM
Not yet recruiting
Phase 2
A clinical trial to assess safety and efficacy of new formulation (NIA/DG-04) in Type 2 Diabetes MellitusHealth Condition 1: E119- Type 2 diabetes mellitus without complications
CTRI/2022/03/041358ational Institute Of Ayurveda Jaipur
Recruiting
Not Applicable
Study of effectiveness and safety of rosuvastatin, aspirin and clopidogrel in patients with acute coronary syndromeHealth Condition 1: I20-I25- Ischemic heart diseases
CTRI/2019/01/017221Aprica Healthcare Pvt Ltd