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

NCT01795664 | Completed Phase 3

• 3 other identifiers: FLUI-2012-942012-005789-36E-RES/12/12-Q13
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Secondary Outcomes (7)

• Lung function tests (spirometry, body plethysmography)

  At visit 2 (= 7-11 days after visit 1)

• Exercise capacity (6 minutes walking test)

  At visit 2 (= 7-11 days after visit 1)

• Dyspnea (BORG CR 10 scale and VAS dyspnea)

  At visit 2 (= 7-11 days after visit 1)

• Incidence of adverse events

  From visit 1 until visit 4 = timeperiod of 3 à 4 weeks

• Lung function tests (spirometry, body plethysmography)

  At visit 3 (= 3-7 days after visit 2)

Study Arms (2)

Seretide Evohaler

ACTIVE COMPARATOR

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

Radiation: Functional Respiratory Imaging; Drug: Seretide Evohaler; Drug: Placebo of Test product

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

EXPERIMENTAL

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

Radiation: Functional Respiratory Imaging; Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI; Drug: Placebo of Reference product

Interventions

Functional Respiratory Imaging 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; Seretide Evohaler

Salmeterol xinafoate and Fluticasone propionate HFA pMDI 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)

Also known as: Test product

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Seretide Evohaler 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)

Also known as: Reference product, Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI

Seretide Evohaler

Placebo of Test product DRUG

Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Also known as: Placebo inhaler containing HFA propellant resembling the test active inhaler

Seretide Evohaler

Placebo of Reference product DRUG

Single dose of 2 puffs To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day.

Also known as: Placebo inhaler containing HFA propellant resembling the reference active inhaler

Salmeterol xinafoate and Fluticasone propionate HFA pMDI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• FLUIDDA nv: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 27227384 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Wilfried De Backer, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 21, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 19, 2013

Record last verified: 2013-09

Locations

BE (1)