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Completed

NCT Number: NCT01471340

A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)

The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.

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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 4

About this study

Amendments 2 and 3 are specific to Brazil; all other countries will enroll patients under Amendment 1.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Persistent asthma for at least 1-year
  • Must use a daily asthma controller medication for at least 4 weeks prior to randomization, including an inhaled corticosteroid (ICS) with or without a long-acting beta agonist (LABA) or other adjunctive asthma therapy OR be using a leukotriene receptor antagonist (LTRA), xanthine or short acting beta agonist (SABA) as a monotherapy.
  • Must be able to discontinue current asthma medication
  • Must have a history of at least one asthma exacerbation in previous 4 to 52 weeks

Exclusion criteria

  • Unstable asthma
  • Taking high dose ICS with or without other adjunctive therapy who have an Asthma Control Questionnaire 6 (ACQ6) total score ≥ 1.5
  • Taking LTRA, xanthine or SABA monotherapy with an ACQ-6 total score < 1.5 (controlled)
  • Chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF), or other significant, non-asthmatic, lung disease
  • Clinically significant abnormality, illness or disorder of any body or organ system
  • Significant underlying cardiovascular condition which may contraindicate use of a beta-agonist.
  • History of smoking greater than 10-pack years
  • Had an asthma exacerbation within 4 weeks of the Baseline Visit
  • Had more than 4 asthma exacerbations or 2 hospitalizations within 52 weeks of the randomization visit
  • Known or suspected hypersensitivity or intolerance to corticosteroids, beta-2 agonists, or any of the (inactive ingredients) excipients present in the medications used in this study
  • Require the use of chronic systemic steroids, omalizumab, or other monoclonal or polyclonal antibodies
  • Requires the use of beta-blockers
  • History of life-threatening asthma, including an asthma episode that required intubation and/or was associated with hypercapnia requiring noninvasive ventilatory support
  • Lactating, pregnant, or plans to become pregnant during the course of the trial

Treatment and study plan

Mometasone Furoate/Formoterol MDI 100/5 mcg

Drug

two inhalations BID

Other names: MK-0887A; Dulera/Zenhale

Mometasone Furoate/Formoterol MDI 200/5 mcg

Drug

two inhalations BID

Other names: MK-0887A; Dulera/Zenhale

Mometasone Furoate MDI 100 mcg

Drug

two inhalations BID

Other names: Asmanex

Mometasone Furoate MDI 200 mcg

Drug

two inhalations BID

Other names: Asmanex

Albuterol 90 mcg /salbutamol 100 mcg HFA MDI

Drug

use as needed for asthma symptoms

prednisone/prednisolone

Drug

Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator

Primary outcomes

  1. Time-to-First Serious Asthma Outcomes (SAO): Number of First SAO in the MF/F vs MF Arms

    Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

    The primary safety outcome was the time-to-first SAO (a composite endpoint of adjudicated asthma-related hospitalizations, adjudicated asthma-related intubations, and adjudicated asthma-related deaths). To accomplish this, the number of participants experiencing a first SAO was collected for 26 weeks following initiation of study treatment (or 7 days after the last treatment dose, whichever occurred later). Data generated by this methodology were used to compute a hazard ratio (HR) and 95% confidence interval (CI), modeling the likelihood of a first SAO occurring at any given time in the MF/F arm relative to the MF arm. Although data were sufficient to generate a HR and 95% CI, time-to-first SAO in the overall population could not be accurately reported due to insufficient SAO occurrence. Therefore, the number of first SAO in either arm is reported as a descriptive measure. For each participant, first SAO denotes first event per participant.

Secondary outcomes

  1. Time-to-First Severe Asthma Exacerbation (SAEX): Number of First SAEX in the MF/F vs MF Arms

    Time frame: 26 weeks, plus 7 days after the last treatment

    The key secondary efficacy outcome was time-to-first protocol-defined asthma exacerbation (SAEX). The SAEX were deteriorations of asthma requiring: use of systemic corticosteroids (tablets, suspension, or injection) for >= 3 consecutive days, in-patient hospitalization >= 24 hours, or an emergency department (ED) visit < 24 hours that required systemic corticosteroids in the MF/F MDI BID arm versus the MF MDI BID arm. The number of first SAEX occurred from initiation of study treatment to 7 days after the last treatment (modified intention-to-treat). This outcome was measured as the HR and 95% CI for the number of first SAEX in the MF/F MDI BID arm versus the number of first SAEX in the MF MDI BID arm. Given insufficient data for SAEX events, it was not informative to report the time-to-first SAEX in the overall population. Therefore, the number of first SAEXs in either arm is reported as a descriptive measure. For each participant, first SAEX denotes first event per participant.

Other outcomes

  1. Number of SAO Components in MF/F Participants vs MF Participants

    Time frame: 26 weeks, or 7 days after the last treatment dose, whichever occurred later

    To further examine the primary safety outcome, each adjudicated component of the SAO composite endpoint (asthma-related hospitalization, asthma-related intubation and asthma-related death), was tabulated for descriptive purposes only to show the relative contribution of each component to the SAO composite. Hospitalizations were defined as an in-patient stay of >= 24 hour in a hospital, emergency department or equivalent healthcare facility. Intubation was defined as endotracheal intubation only.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A 26-Week Randomized, Double-Blinded, Active Controlled Study Comparing the Safety of Mometasone Furoate/Formoterol Fumarate MDI Fixed Dose Combination Versus Mometasone Furoate MDI Monotherapy in Adolescents and Adults With Persistent Asthma (Protocol No. P06241 Also Known as P202)

Acronym: SPIRO

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 16, 2011
Registry last updated
May 23, 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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