An Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy and Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent and Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Research Limited
ClinicalTrials.gov Identifier:
NCT00563056
First received: November 21, 2007
Last updated: August 9, 2012
Last verified: August 2012
  Purpose

Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.


Condition Intervention Phase
Asthma Bronchiale
Drug: Flutiform
Drug: Flixotide plus Foradil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma

Resource links provided by NLM:


Further study details as provided by Mundipharma Research Limited:

Primary Outcome Measures:
  • Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 227
Study Start Date: September 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Flutiform
2 puffs 50/5 or 125/5 mcg
Drug: Flutiform
Active Comparator: Flixotide plus Foradil
Flixotide 2 puffs 50 or 125 mcg; Foradil 1 puff 12 mcg
Drug: Flixotide plus Foradil

Detailed Description:

This is a study involving a 12 week treatment phase. During the treatment phase subjects receive Flutiform® or Flixotiole® and Foradil® as individual componements. Efficacy will be assessed by lung function tests and asthma symptoms, sleep disturbance. Safety will be assessed by adverse events, vital signs, lab tests and ECGs.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
  2. Known history of mild to moderate-severe persistent, reversible asthma for ≥ 6 months prior to the screening visit.
  3. Demonstrate a FEV1 of ≥40% to ≤85% for predicted normal values (Quanjer et al, 19931) during the screening phase following appropriate withholding of asthma medications (if applicable).

    • No β2-agonist use on day of screening.
    • No use of inhaled combination asthma therapy on day of screening.
    • Inhaled corticosteroids are allowed on day of screening.
  4. Documented reversibility of ≥15% in FEV1 in the screening phase.
  5. Demonstrate satisfactory technique in the use of the study medications.
  6. Willing and able to enter information in the diary and attend all study visits.
  7. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
  8. Written informed consent obtained

Exclusion criteria:

  1. Near fatal or life-threatening (including intubation) asthma within the past year.
  2. Hospitalization or an emergency visit for asthma within the past year.
  3. History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
  4. History of omalizumab use within the past 6 months.
  5. History of leukotriene receptor antagonist use, e.g. montelukast, or theophylline within the past week.
  6. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
  7. In the investigators opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
  8. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
  9. Known Human Immunodeficiency Virus (HIV)-positive status.
  10. A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
  11. Current smoking history within 12 months prior to the Screening Visit.
  12. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
  13. Subjects who have taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
  14. Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
  15. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
  16. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
  17. Current participation in a clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00563056

Locations
Germany
Research Site
Kassel, Germany
Hungary
Research Site
Erd, Hungary
Netherlands
Research site
Nieuwegein, Netherlands
Poland
Research Site
Krakow, Poland
Romania
Research Site
Cluj-Napoca, Romania
United Kingdom
Research Site
Chesterfield, United Kingdom
Sponsors and Collaborators
Mundipharma Research Limited
  More Information

Additional Information:
No publications provided by Mundipharma Research Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mundipharma Research Limited
ClinicalTrials.gov Identifier: NCT00563056     History of Changes
Other Study ID Numbers: FLT3505, 2007-001634-13
Study First Received: November 21, 2007
Last Updated: August 9, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by Mundipharma Research Limited:
Formoterol
Fluticasone
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014