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Completed

NCT Number: NCT02039011

Ultra-long Acting Bronchodilator Therapy in Asthmatics

Asthma is a common condition which produces a significant workload for general practice, hospital outpatient clinics and inpatient admissions. Asthma is caused by inflammation of the airways which irritates the muscles around the airways causing them to constrict. The mainstay of asthma treatment is inhaled steroids. If the patients' symptoms are still not adequately controlled, then a long-acting beta agonist (LABA) inhaler which relaxes the muscles in the airways and opens it up is frequently added to the inhaled steroids. Despite this, a substantial proportion of asthmatic patients still do not achieve adequate control of their symptoms. Recent studies have shown when an alternative inhaler called a long-acting muscarinic antagonist (LAMA) is added to a LABA - it reduced the number of asthma exacerbations (flare-ups) and improved airway narrowing.

The mannitol challenge is a test of airway 'twitchiness', an important feature of asthma. There have been no previous studies assessing the combined effects LABA and LAMA inhalers on mannitol challenge. The mannitol challenge is particularly relevant as it mimics stimuli encountered in real life which provoke an asthma attack.

The investigators propose to directly compare indacaterol, a new once-daily LABA with indacaterol plus tiotropium, a once-daily LAMA, as add-on treatment to inhaled steroids in persistent asthmatics using the mannitol challenge. The investigators hope that this study will help us understand how the combination of a LABA and LAMA might help protect against flare-ups.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asthma and Allergy Research Group, University of Dundee

Dundee, DD1 3AU, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female volunteers aged at least 16 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms of beclomethasone dipropionate or the equivalent
  • FEV1 > 50 % predicted
  • Mannitol PD15 < 635 mg
  • Ability to give informed consent
  • Agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion criteria

  • Other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or allergic bronchopulmonary aspergillosis
  • An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement
  • Any clinically significant medical condition that may endanger the health or safety of the participant
  • Smoking within one year or >10 pack year history
  • Participation in another trial within 30 days before the commencement of the study
  • Pregnancy or lactation
  • Unable to comply with the procedures of the protocol

Treatment and study plan

Indacaterol

Drug

Participants receive indacaterol for 2 to 4 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Indacaterol and tiotropium

Drug

Participants receive indacaterol and tiotropium for 2 to 4 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Primary outcomes

  1. Change in provocation dose of mannitol causing 15% drop in forced expiratory volume in 1 second (PD15) between single and chronic dosing of ultra-long acting bronchodilator therapy

    Time frame: 2 to 4 weeks

Secondary outcomes

  1. Mannitol Response-dose Ratio (RDR)

    Time frame: 2 to 4 weeks

  2. Salbutamol recovery time following mannitol challenge

    Time frame: 2 to 4 weeks

  3. Domiciliary peak expiratory flow (PEF)

    Time frame: 2 to 4 weeks

  4. Trough forced expiratory volume in 1 second (FEV1)

    Time frame: 2 to 4 weeks

  5. Exhaled nitric oxide (FeNO)

    Time frame: 2 to 4 weeks

  6. Trough impulse oscillometry (IOS)

    Time frame: 2 to 4 weeks

  7. Asthma Control Questionnaire (ACQ)

    Time frame: 2 to 4 weeks

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Tenovus Scotland

Registry information

Official study title

Proof of Concept Study to Evaluate Single and Chronic Dosing Effects of Ultra-long Acting Bronchodilator Therapy on Mannitol Challenge in Asthmatic Patients Taking Inhaled Corticosteroids

Acronym: MAN02

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 17, 2014
Registry last updated
Apr 12, 2019

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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