Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma

NCT01099722 | Completed Phase 3

• 2 other identifiers: FLT35072009-017223-25
• Study Type: interventional
• Target: 261
• Locations: 5 countries
• Sites: 5

Brief Summary

A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.

Conditions

Asthma

Keywords

moderate to severe persistent reversible asthma

Outcome Measures

Primary Outcomes (1)

• non-inferiority in the efficacy of FlutiForm®

  To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre morning dose value of forced expiratory volume in the first second (FEV1) from baseline (end of run-in period) to the end of the 12 week treatment period.

  baseline to the end of the 12 week treatment

Secondary Outcomes (1)

• Additional efficacy and safety assessments

Study Arms (2)

Inhaler

ACTIVE COMPARATOR

Drug: Flutiform; Drug: Symbicort Turbohaler

inhaler

ACTIVE COMPARATOR

Symbicort

Drug: Symbicort Turbohaler

Interventions

Flutiform DRUG

inhaler 2 puffs bd daily

Inhaler

Symbicort Turbohaler DRUG

2 puffs bd daily

Inhaler; inhaler

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects at least 12 years old
• Female subjects less than 1 year post-menopausal must have a negative urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, \& willing to use adequate \& highly effective methods of contraception throughout the study. 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 \& correctly such as sterilisation, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.
• Known history of moderate to severe persistent, reversible asthma for ≥ 6 months prior to the Screening Visit characterised by:
• Treatment with an inhaled corticosteroid (ICS) at a dose of 250 - 1000 µg fluticasone or equivalent OR Treatment wth ICS at a dose of 200-500 µg fluticasone or equivalent in combination with a Long Acting β2-Agonist (LABA).
• Demonstrated a FEV1 of ≥ 50% to ≤ 80% for predicted normal values (Quanjer et al., 1993 (adults), \& 1995 (adolescents)) during the Screening Period (Visit 1 or Visit 2) following appropriate withholding of asthma medications (if applicable).
• No β2-agonist use on day of testing
• No use of inhaled combination asthma therapy on day of testing.
• Inhaled corticosteroids are allowed on day of testing.
• Documented reversibility of ≥ 15% in FEV1 at visit 1 or visit 2.
• Demonstrated satisfactory technique in the use of the study medications i.e. pMDI and Dry Powder Inhaler (DPI) devices.
• Willing \& able to enter information in the electronic diary \& attend all study visits.
• Willing \& able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.

You may not qualify if:

• Near fatal or life-threatening (including intubation) asthma within the past year.
• Hospitalisation or an emergency visit for asthma within the 4 weeks before the Screening Visit.
• Known history of systemic (injectable or oral) corticosteroid medication use within 1 month of the Screening Visit.
• Known history of omalizumab use within the past 6 months.
• Current evidence or known 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 subject at risk through study participation, or which would affect the outcome of the study.
• In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
• Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
• Known Human Immunodeficiency Virus (HIV)-positive status.
• Subject has 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.).
• Current smoking history within 12 months prior to the Screening Visit.
• Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
• Subject has 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.
• Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm \&/or pulmonary function.
• Current evidence or known history of hypersensitivity or idiosyncratic reaction to test medications or components.
• Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (5)

Unknown Facility

Sofia, Bulgaria

Location

Csongrád Megyei Önkormányzat Mellkasi Betegségek Szakkórháza Tüdőgondozó Intézet

Szeged, Hungary

Location

Unknown Facility

Indore, India

Location

Unknown Facility

Krakow, Poland

Location

Unknown Facility

Brasov, Romania

Location

Related Publications (1)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

Related Links

• Results available on website

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterol

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 7, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

IN (1); PL (1); HU (1); RO (1); BU (1)