Study to compare the effects of Seretide® Evohaler and a generic Seretide variant on respiratory imaging parameters in asthmatic patients.

Phase 1

• Conditions: Asthma; MedDRA version: 15.1Level: LLTClassification code 10049106Term: Asthma chronicSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 15.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 15.1Level: LLTClassification code 10003565Term: AsthmaticSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 15.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005789-36-BE
• Lead Sponsor: FluidDA nv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-29
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female patient = 18 years old
2. Written informed consent obtained
3. Patient with a documented diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
4. Patient with a co-operative attitude and ability to be trained to correctly use the Seretide® and Cipla Seretide generic MDI
5. Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
6. Patient must be stable and treated in accordance with the GINA guidelines
7. Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to the visit 1 and has a smoking history of < 10 pack years
8. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

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 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Pregnant or lactating female
2. Unstable patient who developed an exacerbation during the last 8 weeks
3. Patient with upper or lower airways infection
4. Patient unable to carry out pulmonary function testing
5. Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
6. Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
7. Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
8. Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
9. Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
10. Patient who received any investigational new drug within the last 4 weeks prior to visit 1 or twice the duration of the biological effect of any drug (whichever is longer).
11. Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
12. Patient who has undergone major surgery in the last 12 weeks before the visit 1 or has planned to undergo a major surgery before the end of the trial
13. Patient with diagnosis of COPD

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified