Clinical trial NCT01795664: Compare the Effects of Seretide® Evohaler and a Generic Salmeterol/Fluticasone Hydrofluoroalkane (HFA) Pressurized Metered-dose Inhaler (pMDI) on Functional Respiratory Imaging Parameters in Asthmatic Patients
Official title: A Double Blind, Double Dummy, Randomized, Two Way Cross-over Study to Compare the Effects of Seretide® Evohaler (Supplied by Allen & Hanburys, UK) and a Generic Salmeterol/Fluticasone HFA pMDI (Manufactured by Cipla Ltd, India) on Functional Respiratory Imaging Parameters in Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Salmeterol xinafoate and Fluticasone propionate
Seretide Evohaler
Functional Respiratory Imaging
Computational Fluid Dynamic
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2013-02-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted as a randomized, double blind, double dummy two period crossover study in stable asthma patients. A total of 16 stable asthma patients treated in accordance with the Global Initiative for Asthma (GINA) guidelines, will be included.

Objectives:

* The primary objective of this study is to evaluate the effect of both the study drugs under investigation on Functional Respiratory Imaging (FRI) parameters and to evaluate the particle deposition in the lungs using Computational Fluid Dynamic (CFD)
* The secondary objectives are to assess the effect of both the study drugs on lung function (spirometry and body plethysmography), on exercise capacity (6 Minutes Walking Test = 6MWT) and on dyspnea (Borg Category (C) Ratio (R) 10 Scale and Visual Analog Scale (VAS) dyspnea). Furthermore the safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.


Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Written informed consent obtained
* Patient with a documented diagnosis of asthma according to the GINA guidelines
* Patient with a co-operative attitude and ability to be trained to correctly use the pMDI
* 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
* Patient must be stable and treated in accordance with the GINA guidelines
* Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to visit 1 and has a smoking history of \< 10 pack years
* Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions

Exclusion Criteria:

* Pregnant or lactating female
* Unstable patient who developed an exacerbation during the last 8 weeks
* Patient with upper or lower airways infection
* Patient unable to carry out pulmonary function testing
* 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
* Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
* Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
* Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
* Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
* 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)
* Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
* 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
* Patient with diagnosis of chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Total airway volume
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: The number of deposited particles per pre-defined airway section
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: Total airway resistance
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: Total airway volume
timeFrame: At visit 3 (= 3-7 days after visit 2)
measure: The number of deposited particles per pre-defined airway section
timeFrame: At visit 3 (= 3-7 days after visit 2)
measure: Total airway resistance
timeFrame: At visit 3 (= 3-7 days after visit 2)
Secondary outcomes:
measure: Lung function tests (spirometry, body plethysmography)
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: Exercise capacity (6 minutes walking test)
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: Dyspnea (BORG CR 10 scale and VAS dyspnea)
timeFrame: At visit 2 (= 7-11 days after visit 1)
measure: Incidence of adverse events
timeFrame: From visit 1 until visit 4 = timeperiod of 3 à 4 weeks
measure: Lung function tests (spirometry, body plethysmography)
timeFrame: At visit 3 (= 3-7 days after visit 2)
measure: Exercise capacity (6 minutes walking test)
timeFrame: At visit 3 (= 3-7 days after visit 2)
measure: Dyspnea (BORG CR 10 scale and VAS dyspnea)
timeFrame: At visit 3 (= 3-7 days after visit 2)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Wilfried De Backer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Backer J, Van Holsbeke C, Vos W, Vinchurkar S, Dorinsky P, Rebello J, Mangale M, Hajian B, De Backer W. Assessment of lung deposition and analysis of the effect of fluticasone/salmeterol hydrofluoroalkane (HFA) pressurized metered dose inhaler (pMDI) in stable persistent asthma patients using functional respiratory imaging. Expert Rev Respir Med. 2016 Aug;10(8):927-33. doi: 10.1080/17476348.2016.1192464. Epub 2016 Jun 1.