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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795664
• Other study ID #: FLUI-2012-94
• Secondary ID: 2012-005789-36E-
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2013
• Last updated: September 18, 2013
• Start date: March 2013
• Est. completion date: August 2013

Study information

• Verified date: September 2013
• Source: FLUIDDA nv
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Radiation:
• Functional Respiratory Imaging
CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

Drug:
• Salmeterol xinafoate and Fluticasone propionate HFA pMDI
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design)
• Seretide Evohaler
Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg At visit 2 or visit 3 (cross-over design)
• Placebo of Test product
Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.
• Placebo of Reference product
Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
FLUIDDA nv

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total airway volume	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)	At visit 2 (= 7-11 days after visit 1)	No
Primary	The number of deposited particles per pre-defined airway section	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)	At visit 2 (= 7-11 days after visit 1)	No
Primary	Total airway resistance	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)	At visit 2 (= 7-11 days after visit 1)	No
Primary	Total airway volume	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)	At visit 3 (= 3-7 days after visit 2)	No
Primary	The number of deposited particles per pre-defined airway section	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)	At visit 3 (= 3-7 days after visit 2)	No
Primary	Total airway resistance	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)	At visit 3 (= 3-7 days after visit 2)	No
Secondary	Lung function tests (spirometry, body plethysmography)	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).	At visit 2 (= 7-11 days after visit 1)	No
Secondary	Exercise capacity (6 minutes walking test)	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).	At visit 2 (= 7-11 days after visit 1)	No
Secondary	Dyspnea (BORG CR 10 scale and VAS dyspnea)	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).	At visit 2 (= 7-11 days after visit 1)	No
Secondary	Incidence of adverse events	The safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.	From visit 1 until visit 4 = timeperiod of 3 à 4 weeks	Yes
Secondary	Lung function tests (spirometry, body plethysmography)	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).	At visit 3 (= 3-7 days after visit 2)	No
Secondary	Exercise capacity (6 minutes walking test)	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).	At visit 3 (= 3-7 days after visit 2)	No
Secondary	Dyspnea (BORG CR 10 scale and VAS dyspnea)	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).	At visit 3 (= 3-7 days after visit 2)	No