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Completed

NCT Number: 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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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)

Other names: Test product

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)

Other names: Reference product, Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI

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.

Other names: Placebo inhaler containing HFA propellant resembling the test active inhaler

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.

Other names: Placebo inhaler containing HFA propellant resembling the reference active inhaler

Primary outcomes

  1. Total airway volume

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

    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)

  2. The number of deposited particles per pre-defined airway section

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

    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)

  3. Total airway resistance

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

    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)

  4. Total airway volume

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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)

  5. The number of deposited particles per pre-defined airway section

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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)

  6. Total airway resistance

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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)

Secondary outcomes

  1. Lung function tests (spirometry, body plethysmography)

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

    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).

  2. Exercise capacity (6 minutes walking test)

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

    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).

  3. Dyspnea (BORG CR 10 scale and VAS dyspnea)

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

    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).

  4. Incidence of adverse events

    Time frame: From visit 1 until visit 4 = timeperiod of 3 à 4 weeks

    The safety of the 2 products under investigation will be evaluated through monitoring of adverse events (AEs) throughout the study.

  5. Lung function tests (spirometry, body plethysmography)

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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).

  6. Exercise capacity (6 minutes walking test)

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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).

  7. Dyspnea (BORG CR 10 scale and VAS dyspnea)

    Time frame: At visit 3 (= 3-7 days after visit 2)

    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).

Sponsors and collaborators

Lead sponsor

FLUIDDA nv

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 21, 2013
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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