NCT02415179

Brief Summary

The purpose of this study is to investigate the effectiveness of inhaled mometasone/formoterol versus inhaled fluticasone/salmeterol on peripheral airway function in treatment of asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

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

January 29, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 26, 2016

Status Verified

April 1, 2016

Enrollment Period

9 months

First QC Date

January 29, 2015

Last Update Submit

April 25, 2016

Conditions

Asthma

Keywords

Newly diagnosed asthmaperipheral airway function

Outcome Measures

Primary Outcomes (1)

  • Peripheral airway function measured by impulse oscillometry

    The measuring of airway resistance at 5 and 20 Hz

    6 weeks

Secondary Outcomes (6)

  • Peak expiratory flow rate

    6 weeks

  • Forced expiratory volume at 1 second

    6 weeks

  • Forced vital capacity

    6 weeks

  • Forced expiratory flow rate at 25-75% of vital capacity

    6 weeks

  • Asthma control test score

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

Inhaled Mometasone/formoterol

EXPERIMENTAL

Inhaled Mometasone/Formoterol (100/5 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks

Drug: Inhaled Mometasone/formoterol

Inhaled Fluticasone/Salmeterol

ACTIVE COMPARATOR

Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks

Drug: Inhaled Fluticasone/Salmeterol

Interventions

Inhaled Mometasone/formoterolDRUG

Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks

Inhaled Mometasone/formoterol
Inhaled Fluticasone/SalmeterolDRUG

Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks

Inhaled Fluticasone/Salmeterol

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed asthma according to Global Initiative for Asthma (GINA) guideline 2014 without previous treatment of inhaled corticosteroid and long acting beta agonists
  • Patients with asthma symptoms of most days or wake up due to asthma one time per week or more
  • Patients with the presence of any risk factors of asthma according to Global Initiative for Asthma (GINA) guideline 2014
  • Patients with severe uncontrolled asthma
  • Patients with previous asthma exacerbation
  • Patients give consent form

You may not qualify if:

  • Patients with contra-indication for performing spirometry according to American Thoracic Society (ATS) and European Respiratory Society (ERS) statement of standardization for spirometry
  • Patients refuse to participate study -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Ramathibodi Hospital

Bangkok, Thailand

Location

Related Publications (7)

  • Kraft M, Pak J, Martin RJ, Kaminsky D, Irvin CG. Distal lung dysfunction at night in nocturnal asthma. Am J Respir Crit Care Med. 2001 Jun;163(7):1551-6. doi: 10.1164/ajrccm.163.7.2008013.

    PMID: 11401872BACKGROUND

  • Martin RJ. Therapeutic significance of distal airway inflammation in asthma. J Allergy Clin Immunol. 2002 Feb;109(2 Suppl):S447-60. doi: 10.1067/mai.2002.121409.

    PMID: 11842317BACKGROUND

  • Usmani OS, Biddiscombe MF, Barnes PJ. Regional lung deposition and bronchodilator response as a function of beta2-agonist particle size. Am J Respir Crit Care Med. 2005 Dec 15;172(12):1497-504. doi: 10.1164/rccm.200410-1414OC. Epub 2005 Sep 28.

    PMID: 16192448BACKGROUND

  • Meltzer EO, Kuna P, Nolte H, Nayak AS, Laforce C; P04073 Study Investigators. Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function. Eur Respir J. 2012 Feb;39(2):279-89. doi: 10.1183/09031936.00020310. Epub 2011 Aug 4.

    PMID: 21828036BACKGROUND

  • Kirsten AM, Watz H, Brindicci C, Piccinno A, Magnussen H. Effects of beclomethason/formoterol and budesonide/formoterol fixed combinations on lung function and airway inflammation in patients with mild to moderate asthma--an exploratory study. Pulm Pharmacol Ther. 2015 Apr;31:79-84. doi: 10.1016/j.pupt.2014.08.007. Epub 2014 Sep 4.

    PMID: 25194884BACKGROUND

  • Bernstein DI, Hebert J, Cheema A, Murphy KR, Cherrez-Ojeda I, Matiz-Bueno CE, Kuo WL, Nolte H. Efficacy and onset of action of mometasone furoate/formoterol and fluticasone propionate/salmeterol combination treatment in subjects with persistent asthma. Allergy Asthma Clin Immunol. 2011 Dec 7;7(1):21. doi: 10.1186/1710-1492-7-21.

    PMID: 22152089BACKGROUND

  • Hozawa S, Terada M, Hozawa M. Comparison of budesonide/formoterol Turbuhaler with fluticasone/salmeterol Diskus for treatment effects on small airway impairment and airway inflammation in patients with asthma. Pulm Pharmacol Ther. 2011 Oct;24(5):571-6. doi: 10.1016/j.pupt.2011.05.004. Epub 2011 May 23.

    PMID: 21624490BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

Formoterol FumarateSalmeterol Xinafoate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesAlbuterolPhenethylaminesEthylamines

Study Officials

  • Tananchai Petnak, M.D.

    Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

  • Theerasuk Kawamatawong, M.D.

    Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

  • Prapaporn Pornsuriyasak, M.D.

    Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

  • Viboon Boonsarngsuk, M.D.

    Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

  • Naparat Amornputtisathaporn, M.D.

    Pulmonary and critical care, Department of Medicine, Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2015

First Posted

April 14, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 26, 2016

Record last verified: 2016-04

Locations

TH(1)