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Trial record 74 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT01795664
Recruitment Status : Completed
First Posted : February 21, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

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.

Condition or disease Intervention/treatment Phase
Asthma Radiation: Functional Respiratory Imaging Drug: Salmeterol xinafoate and Fluticasone propionate HFA pMDI Drug: Seretide Evohaler Drug: Placebo of Test product Drug: Placebo of Reference product Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013


Arm Intervention/treatment
Active Comparator: 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

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

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)

Other Names:
  • Reference product
  • Salmeterol xinafoate and Fluticasone propionate combination HFA pMDI

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.

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

Experimental: 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

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)

Other Name: Test product

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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795664


Locations
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Belgium
Antwerp University Hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
FLUIDDA nv
Investigators
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Principal Investigator: Wilfried De Backer, MD, PhD University Hospital, Antwerp

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT01795664     History of Changes
Other Study ID Numbers: FLUI-2012-94
2012-005789-36 ( EudraCT Number )
E-RES/12/12-Q13 ( Other Identifier: Cipla Ltd, India )
First Posted: February 21, 2013    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013
Keywords provided by FLUIDDA nv:
Asthma
Salmeterol xinafoate and Fluticasone propionate
Seretide Evohaler
Functional Respiratory Imaging
Computational Fluid Dynamic
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists