Ultra-long Acting Bronchodilator Therapy in Asthmatics

NCT ID: NCT02039011

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2016-07-31

Brief Summary

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Indacaterol

Group Type: ACTIVE_COMPARATOR

Indacaterol

Intervention Type: 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 & tiotropium

Group Type: EXPERIMENTAL

Indacaterol and tiotropium

Intervention Type: 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.

Interventions

Indacaterol

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

Intervention Type: DRUG

Indacaterol and tiotropium

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tenovus Scotland

OTHER

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Brian J Lipworth

Professor of Allergy and Pulmonology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Lipworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Arvind Deva Manoharan, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Asthma and Allergy Research Group, University of Dundee

Dundee, , United Kingdom

Countries

United Kingdom

References

Jabbal S, Manoharan A, Lipworth BJ. Bronchoprotective tolerance with indacaterol is not modified by concomitant tiotropium in persistent asthma. Clin Exp Allergy. 2017 Oct;47(10):1239-1245. doi: 10.1111/cea.12972. Epub 2017 Aug 1.

Reference Type: RESULT

PMID: 28665534 (View on PubMed)

Other Identifiers

2012RC15

Identifier Type: -

Identifier Source: org_study_id