NCT01471340

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,744

participants targeted

Target at P75+ for phase_4 asthma

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4 asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

January 9, 2012

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 5, 2018

Completed
Last Updated

May 23, 2024

Status Verified

April 1, 2024

Enrollment Period

4.9 years

First QC Date

November 10, 2011

Results QC Date

November 7, 2017

Last Update Submit

May 9, 2024

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

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

    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.

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

Secondary Outcomes (1)

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

    26 weeks, plus 7 days after the last treatment

Other Outcomes (1)

  • Number of SAO Components in MF/F Participants vs MF Participants

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

Study Arms (2)

Mometasone Furoate/Formoterol MDI BID

EXPERIMENTAL

MF/F MDI BID (pooled MF/F MDI 200/10 mcg BID and MF/F MDI 400/10 mcg BID treatments)

Drug: Mometasone Furoate/Formoterol MDI 100/5 mcgDrug: Mometasone Furoate/Formoterol MDI 200/5 mcgDrug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDIDrug: Prednisone/prednisolone

Mometasone Furoate MDI BID

ACTIVE COMPARATOR

MF MDI BID (pooled from MF MDI 200 mcg BID and MF MDI 400 mcg BID treatments)

Drug: Mometasone Furoate MDI 100 mcgDrug: Mometasone Furoate MDI 200 mcgDrug: Albuterol 90 mcg /salbutamol 100 mcg HFA MDIDrug: Prednisone/prednisolone

Interventions

Mometasone Furoate/Formoterol MDI 100/5 mcgDRUG

two inhalations BID

Also known as: MK-0887A; Dulera/Zenhale
Mometasone Furoate/Formoterol MDI BID
Mometasone Furoate/Formoterol MDI 200/5 mcgDRUG

two inhalations BID

Also known as: MK-0887A; Dulera/Zenhale
Mometasone Furoate/Formoterol MDI BID
Mometasone Furoate MDI 100 mcgDRUG

two inhalations BID

Also known as: Asmanex
Mometasone Furoate MDI BID
Mometasone Furoate MDI 200 mcgDRUG

two inhalations BID

Also known as: Asmanex
Mometasone Furoate MDI BID
Albuterol 90 mcg /salbutamol 100 mcg HFA MDIDRUG

use as needed for asthma symptoms

Mometasone Furoate MDI BIDMometasone Furoate/Formoterol MDI BID
Prednisone/prednisoloneDRUG

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

Mometasone Furoate MDI BIDMometasone Furoate/Formoterol MDI BID

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Weinstein CLJ, Ryan N, Shekar T, Gates D, Lane SJ, Agache I, Nathan RA; SPIRO Investigators. Serious asthma events with mometasone furoate plus formoterol compared with mometasone furoate. J Allergy Clin Immunol. 2019 Apr;143(4):1395-1402. doi: 10.1016/j.jaci.2018.10.065. Epub 2018 Dec 8.

    PMID: 30537475RESULT

  • 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: 36472162DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Mometasone FuroateMometasone Furoate, Formoterol Fumarate Drug CombinationAlbuterolPrednisonePrednisolone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsFormoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical PreparationsPhenethylaminesEthylaminesPregnadienetriols

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 16, 2011

Study Start

January 9, 2012

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

May 23, 2024

Results First Posted

January 5, 2018

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share