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Completed

NCT Number: NCT01566149

Study of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in Adolescents & Adults With Persistent Asthma (P08212)

The purpose of this study is to assess the safety, tolerability & effectiveness of 2 strengths of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI) in the treatment of persistent asthma in adults & adolescents.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of asthma of at least 6 months duration
  • Current use of a medium or high daily dose of an inhaled corticosteroid (ICS) (alone or in combination with a long-acting beta agonist [LABA]) for at least 6 weeks prior to Screening AND must be on a stable asthma regimen (daily dose unchanged) for at least 2 weeks prior to Screening
  • Agrees to change asthma therapy (if changing asthma therapy poses no inherent risk)
  • If female of reproductive potential, agrees to remain abstinent or use 2 acceptable methods of birth control during study participation. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraceptive

Exclusion criteria

  • Treatment in the emergency room (for a severe asthma exacerbation), or admitted to the hospital for management of airway obstruction within previous 3 months
  • Any prior ventilator support for respiratory failure secondary to asthma,
  • Upper or lower respiratory tract infection (viral or bacterial) within previous 2 weeks
  • History of a medical condition that, in the investigator's opinion, may interfere with study participation,
  • History of smoking within previous year or a cumulative smoking history of more than 10 pack-years
  • Known allergy to or intolerance of ICSs, LABAs, or any of the ingredients included in the study medications
  • History of use of illicit drugs
  • Inability to correctly use an oral MDI
  • Pregnant, breastfeeding or plans to become pregnant during study

Treatment and study plan

Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI

Drug

Two oral inhalations per dose

Other names: Zenhale®, SCH 418131, MK-0887A

Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI

Drug

Two oral inhalations per dose

Other names: Zenhale®, SCH 418131, MK-0887A

Primary outcomes

  1. Number of Participants With At Least One Adverse Event (AE)

    Time frame: Up to Week 14

    An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

  2. Number of Participants With At Least One Drug-Related AE

    Time frame: Up to Week 14

    A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator.

  3. Number of Participants With At Least One Serious AE

    Time frame: Up to Week 14

    A serious AE was defined as any untoward medical occurrence or effect that at

    any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; is a congenital anomaly or birth defect; and/or cancer.

  4. Number of Participants Who Discontinued From the Study Due to an AE

    Time frame: Up to Week 12

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product.

Secondary outcomes

  1. Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12

    Time frame: Baseline and Week 12

    Baseline was defined as the highest FEV1 value of three assessments prior to first dose of study drug. If two (or all three) spirometry efforts had identical FEV1, the FEV1 from the effort with the highest Forced Vital Capacity (FVC) was to be recorded. Week 12 FEV1 was assessed as the morning FEV1 at the end of the dosing interval (trough FEV1). For participants who discontinued prior to Week 12, the FEV1 measurement from the discontinuation visit was to be be carried forward to Week 12 if (and only if) the participant's study medication compliance rate prior to discontinuation was at least 85%.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

An Open-Label Study to Assess the Safety and Tolerability of Zenhale® (a Fixed-Dose Combination of Mometasone Furoate/Formoterol Fumarate Delivered by Metered Dose Inhaler) in 40 Subjects With Persistent Asthma (Protocol No. 206-00 [P08212])

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2012
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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