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Trial record 3 of 6 for:    napp pharmaceuticals

A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down

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ClinicalTrials.gov Identifier: NCT02388373
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : June 21, 2016
Sponsor:
Collaborator:
Napp Pharmaceuticals Limited
Information provided by (Responsible Party):
Research in Real-Life Ltd

Brief Summary:

The aim of this study is to compare two licensed asthma inhalers and to then evaluate the safety of reducing treatment when patient's asthma is in control. The inhalers used in this study are the Seretide® 250 Evohaler®, which is widely used in UK, and a recently licensed inhaler called Flutiform®. National guidelines recommend that asthma medication should be increased when patients are experiencing worsening of their asthma, and reduced when asthma is in control. However, it is likely that in daily clinical practice some patients are over-treated. It is therefore necessary to conduct more studies which demonstrate that reducing treatment dosage can be done safely.

This study has two phases. In the first phase the investigators aim to recruit 224 patients through approximately 40 clinics in the UK and Ireland. One third of these patients will be selected in random to use the high dosage Seretide® 250 Evohaler® and two thirds will use high dose Flutiform® 250 inhaler for 12 weeks. At the end of phase 1 the investigators will compare how well asthma was controlled between the two groups.

After phase 1 those patients who used Flutiform and did not have any problems with their asthma can participate in phase 2. In phase 2 half of the patients will stay on high dosage Flutiform 250 and half will be switched to the medium dosage Flutiform 125 inhaler. At the end of phase 2 the investigators will compare asthma control between the two groups.

This study will be conducted by Research in Real Life Ltd (Cambridge, UK) with partial funding from Napp Pharmaceuticals Ltd. The estimated total duration of the study is 18 months and each patient will spend a maximum of 6 months in the study.


Condition or disease Intervention/treatment Phase
Asthma Drug: Fluticasone 250/formoterol 10 Drug: Fluticasone 250/salmeterol 25 Drug: Fluticasone 125/formoterol 5 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down
Study Start Date : July 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone

Arm Intervention/treatment
Active Comparator: Seretide 250
Seretide® Evohaler® 25 microgram /50 microgram per metered dose pressurised inhalation, suspension. 25 micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms of fluticasone propionate. This is equivalent to a delivered dose (ex actuator) of 21 micrograms of salmeterol and 220 micrograms of fluticasone propionate. 2 puffs twice daily for 12 weeks Phase 1.
Drug: Fluticasone 250/salmeterol 25
Other Name: Seretide 250 Evohaler

Active Comparator: Flutiform 250
flutiform® 250 microgram/10 microgram per actuation pressurised inhalation, suspensions. 250 micrograms of fluticasone propionate and 10 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 230 microgram of fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate. 2 puffs twice daily for 12 weeks in Phase 1 and 12 weeks in Phase 2.
Drug: Fluticasone 250/formoterol 10
Other Name: Flutiform 250

Active Comparator: Flutiform 125
flutiform 125 microgram/5 microgram per actuation pressurised inhalation, suspensions. 125 micrograms of fluticasone propionate and 5 micrograms of formoterol fumarate dihydrate. This is equivalent to a delivered dose (ex-actuator) of approximately 115 microgram of fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. 2 puffs twice daily for 12 weeks in Phase 2.
Drug: Fluticasone 125/formoterol 5
Other Name: Flutiform 125




Primary Outcome Measures :
  1. Asthma Control Questionnaire score (ACQ7) [ Time Frame: 12 weeks ]
    At week 12 in Phase 1 and Phase 2


Secondary Outcome Measures :
  1. Lung function (FEV1 and FVC) [ Time Frame: 4 or 12 weeks ]
    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  2. Lung inflammation measured as level of Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: 4 or 12 weeks ]
    Phase 2 only (interim visit at week 4 and final visit at week 12)

  3. Asthma control defined by Global Initiative of Asthma (GINA) guidelines at week 12 adjusting for baseline [ Time Frame: 4 or 12 weeks ]
    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  4. Visual Analog Scale (VAS) Score at week 12 adjusting for baseline [ Time Frame: 4 or 12 weeks ]
    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  5. Quality of life measured with Mini Asthma Quality of Life questionnaire at week 12 adjusting for baseline [ Time Frame: 4 or 12 weeks ]
    At week 12 in Phase 1 and Phase 2 and at week 4 interim visit in Phase 2

  6. Proportion of patients with asthma control [ Time Frame: 12 weeks ]
    Phase 1 and Phase 2; Asthma control defined as No exacerbations, No change in therapy, and GINA asthma control achieved

  7. Number of adverse events [ Time Frame: 12 weeks ]
    Phase 1 and Phase 2

  8. Blood eosinophil count [ Time Frame: Phase 2 baseline ]
  9. Asthma Control Questionnaire score (ACQ7) at week 4 in Phase 2 [ Time Frame: 4 weeks (Phase 2 interim visit) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide written informed consent and to comply with the study protocol.
  • Current diagnosis of asthma (as evidenced by appropriate diagnostic code)
  • Received Seretide® 250 Evohaler® 2 puffs twice daily for the last 6 months
  • No asthma exacerbation* in last 3 months
  • ≤2 exacerbations* in last 12 months
  • No errors in device use after training (during baseline visit)
  • Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD) known to have a failure rate of less than 1% per year, steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, abstinence, and partner vasectomy.

    • Exacerbation defined as acute course of oral steroids, emergency room attendance and/or hospitalisation for asthma

Exclusion Criteria:

  • Other chronic respiratory disease than asthma (e.g. Chronic Obstructive Pulmonary Disease (COPD))
  • Uncontrolled asthma (GINA criteria)
  • The patient has used a clinical trial investigational drug within the last year before the screening visit
  • Hypersensitivity to Flutiform®, its component Formoterol or its excipients
  • Pregnant subjects

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): NCT02388373


Locations
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United Kingdom
Research in Real Life Ltd
Cambridge, United Kingdom, CB24 3BA
Sponsors and Collaborators
Research in Real-Life Ltd
Napp Pharmaceuticals Limited
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Responsible Party: Research in Real-Life Ltd
ClinicalTrials.gov Identifier: NCT02388373    
Other Study ID Numbers: OR00213
2013-005365-39 ( EudraCT Number )
First Posted: March 17, 2015    Key Record Dates
Last Update Posted: June 21, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be publically released as this was not covered by patient consent. Patients have consented for anonymised data to be used for future medical research by Research in Real-Life.
Additional relevant MeSH terms:
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Fluticasone
Xhance
Formoterol Fumarate
Salmeterol Xinafoate
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