Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202008893896971 Date of Approval: 17/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title HANDLING USI20 Study: Satisfaction assessment and Good Usage Practice of RS01® versus Handihaler® inhalers in patients with COPD, a randomized comparative multicenter study
Official scientific title Satisfaction assessment and Good Usage Practice of RS01® versus Handihaler® inhalers in patients with COPD, a randomized comparative multicenter study
Brief summary describing the background and objectives of the trial The RS01® inhaler is a dry powder inhaler planned to be marketed in Tunisia by Opalia Pharma Recordati Group as part of the marketing authorization for its generic specialty Tiotropium Opalia. For this, a handling evaluation study is proposed to compare the handling of the RS01® inhaler compared the Handihaler® (inhaler of the reference specialty of Tiotropium).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Handling USI20 Study
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 15/07/2020
Actual trial start date 15/07/2020
Anticipated date of last follow up 23/07/2020
Actual Last follow-up date 23/07/2020
Anticipated target sample size (number of participants) 87
Actual target sample size (number of participants) 88
Recruitment status Completed
Publication URL in progress
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Sequence 2 Two Times (Two successive assessments) One hour between the two assessments The patients are asked to respond to a satisfaction questionnaire after using the RS1® inhaler and repeat the same questionnaire interview after using the Handihaler® inhaler 43
Control Group Sequence 1 Two Times (Two successive assessments) One hour between the two assessments The patients are asked to respond to a satisfaction questionnaire after using the Handihaler® inhaler and repeat the same questionnaire interview after using the RS1® inhaler 45 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age ⩾ 18 years old Informed consent, read and signed Patient with COPD No previous use of any of the study devices Consent not signed 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 08/07/2020 Abderrahman Mami Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Raoued Street Ariana 2080 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome A satisfaction questionnaire was developped based on 20 items and administrated to the population study after using of the RS1 or the Handihaler inhalers. The primary endopoint is a quantitative criterion defined by of the number of subjects who had a final score ≥ 80% iassessment questionnaires. After using the study inhalers
Secondary Outcome Mean score of the satisfaction questionnaire for each trial group After using the study inhalers
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Abderrahman University Hospital Raoued Street Ariana 2080 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
OPALIA pharma RECORDATI Group 27, Livre Sterling Street, Berges du Lac 2 Tunis 1053 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OPALIA pharma RECORDATI Group 27, Livre Sterling Street, Berges du Lac 2 Tunis 1053 Tunisia Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
DACIMA Colisee Soula, 5th Floor, Stairs D. Manar II Tunis 2092 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Lamine Megdiche laminemegdiche@gmail.com +21698435111 Abderrahman University Hospital. Raoued Street.
City Postal code Country Position/Affiliation
Ariana 2080 Tunisia Head of Pneumology Department
Role Name Email Phone Street address
Public Enquiries Karima Hezbri hezbri.k@opalia.com.tn +21658581952 27, Livre Sterling Street, Berges du Lac 2
City Postal code Country Position/Affiliation
Tunis 1053 Tunisia Medical Science Liaison. OPALIA pharma RECORDATI Group
Role Name Email Phone Street address
Scientific Enquiries Rabie Razgallah r.razgallah@dacimasoftware.com +21620509729 Colisee Soula, 5th Floor, Stairs D. El Manar II
City Postal code Country Position/Affiliation
Tunis 2092 Tunisia Managing Partner. DACIMA.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results. As results are not available yet. Summary results will be made available soon. Informed Consent Form 12 months controlled access, upon request to the trial sponsor
URL Results Available Results Summary Result Posting Date First Journal Publication Date
As results are not available yet. Summary results will be made available soon. No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information