Ultra-long Acting Bronchodilator Therapy in Asthmatics (MAN02)

University of Dundee

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: Indacaterol and tiotropium

Drug: Indacaterol

Study type

Interventional

Funder types

Other

Identifiers

NCT02039011

2012RC15

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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