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

NCT ID: NCT01795664

Last Updated: 2013-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-08-31

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.

Conditions

Asthma

Keywords

Asthma; Salmeterol xinafoate and Fluticasone propionate; Seretide Evohaler; Functional Respiratory Imaging; Computational Fluid Dynamic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Seretide Evohaler

Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Seretide Evohaler, Allen & Hanburys, UK)

Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg

Group Type: ACTIVE_COMPARATOR

Functional Respiratory Imaging

Intervention Type: RADIATION

CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

Seretide Evohaler

Intervention Type: DRUG

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

Intervention Type: DRUG

Single dose of 2 puffs

To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI (Cipla Ltd., India)

Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; a total dose of 50/500 mcg

Group Type: EXPERIMENTAL

Functional Respiratory Imaging

Intervention Type: RADIATION

CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Intervention Type: DRUG

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 Reference product

Intervention Type: DRUG

Single dose of 2 puffs

To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Interventions

Functional Respiratory Imaging

CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose

Intervention Type: RADIATION

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)

Intervention Type: DRUG

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)

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Test product; Reference product; Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI; Placebo inhaler containing HFA propellant resembling the test active inhaler; Placebo inhaler containing HFA propellant resembling the reference active inhaler

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FLUIDDA nv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wilfried De Backer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 27227384 (View on PubMed)

Other Identifiers

2012-005789-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E-RES/12/12-Q13

Identifier Type: OTHER

Identifier Source: secondary_id

FLUI-2012-94

Identifier Type: -

Identifier Source: org_study_id