Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

NCT ID: NCT02682862

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-11
• Study Completion Date: 2019-05-22

Brief Summary

Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced.

This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.

Detailed Description

Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma.

Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking.

In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke.

Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between:

Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.

Conditions

Asthma

Study Design

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

Study Groups

Spiolto Respimat

olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm

Group Type: EXPERIMENTAL

olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg

Intervention Type: DRUG

Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily

Striverdi Respimat

olodaterol 2.5mcg 2 puffs OD (once daily) for 2-4 weeks. Participants then enter washout period and receive alternative treatment arm

Group Type: ACTIVE_COMPARATOR

olodaterol 2.5 mcg

Intervention Type: DRUG

Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily

Interventions

olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg

Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily

Intervention Type: DRUG

olodaterol 2.5 mcg

Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily

Intervention Type: DRUG

Other Intervention Names

Spiolto Respimat 2.5mcg/2.5mcg; Striverdi Respimat 2.5mcg

Eligibility Criteria

Inclusion Criteria

• Male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily)
• Current smoker
• Forced Expiratory Volume in 1 second (FEV1) ≥ 60 % predicted
• 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 significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis.
• An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required
• Any clinically significant medical condition that may endanger the health or safety of the participant
• Participation in another drug trial within 30 days before the commencement of the study
• Pregnancy or lactation
• Unable to comply with the procedures of the protocol
• Unable or unwilling to consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunny Jabbal, Mb Chb

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Brian Lipworth, MD, Mb Chb

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School

Dundee, Scotland, United Kingdom

Countries

United Kingdom

References

Lipworth B, RuiWen Kuo C, Jabbal S, Chan R. Inhaled triple therapy and airway hyperresponsiveness in persistent asthma. Ann Allergy Asthma Immunol. 2021 May;126(5):597-598. doi: 10.1016/j.anai.2021.01.032. Epub 2021 Feb 3. No abstract available.

Reference Type: DERIVED

PMID: 33548471 (View on PubMed)

Jabbal S, Kuo CR, Lipworth B. Randomized controlled trial of triple versus dual inhaler therapy on small airways in smoking asthmatics. Clin Exp Allergy. 2020 Oct;50(10):1140-1147. doi: 10.1111/cea.13702. Epub 2020 Jul 27.

Reference Type: DERIVED

PMID: 33180376 (View on PubMed)

Other Identifiers

2014-005317-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013RC06

Identifier Type: -

Identifier Source: org_study_id