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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma Bronchiale
• Intervention / Treatment: Drug: Flutiform; 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.

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Kassel, Germany
    • Research Site
• Hungary
  • Erd, Hungary
    • Research Site
• Netherlands
  • Nieuwegein, Netherlands
    • Research Site
• Poland
  • Krakow, Poland
    • Research Site
• Romania
  • Cluj-Napoca, Romania
    • Research Site
• United Kingdom
  • Chesterfield, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of mean Forced Expriatory Volume in the 1st second (FEV1) values.	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Discontinuation, PEFR, rescue medication use, asthma symptom scores, sleep disturbance, AQLQ, exacerbations, patient acceptance	12 weeks

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Publications and helpful links

General Publications

• Bodzenta-Lukaszyk A, van Noord J, Schroder-Babo W, McAulay K, McIver T. Efficacy and safety profile of fluticasone/formoterol combination therapy compared to its individual components administered concurrently in asthma: a randomised controlled trial. Curr Med Res Opin. 2013 May;29(5):579-88. doi: 10.1185/03007995.2013.772506. Epub 2013 Feb 20.

Helpful Links

• Results available on register

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: November 21, 2007
• First Submitted That Met QC Criteria: November 22, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Formoterol; Fluticasone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Formoterol Fumarate
• Other Study ID Numbers: FLT3505; 2007-001634-13