Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

NCT02682862 | Completed Phase 4

• 2 other identifiers: 2013RC062014-005317-23
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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 Withdrawn subjects may be replaced.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.

Conditions

Asthma

Keywords

tiotropium; olodaterol; smoker; cigarette; bronchodilator

Outcome Measures

Primary Outcomes (1)

• Airway resistance at 5Hz (R5)

  measured by Impulse oscillometry (IOS)

  2-4 weeks

Secondary Outcomes (14)

• RF

  2-4 weeks

• X5

  2-4 weeks

• AX

  2-4 weeks

• R5-R20

  2-4 weeks

• R20

  2-4 weeks

Study Arms (2)

Spiolto Respimat

EXPERIMENTAL

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

Drug: olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg

Striverdi Respimat

ACTIVE COMPARATOR

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

Drug: olodaterol 2.5 mcg

Interventions

olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg DRUG

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

Also known as: Spiolto Respimat 2.5mcg/2.5mcg

Spiolto Respimat

olodaterol 2.5 mcg DRUG

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

Also known as: Striverdi Respimat 2.5mcg

Striverdi Respimat

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

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

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 33548471 DERIVED

• 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.

  PMID: 33180376 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide; tiotropium-olodaterol; olodaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Sunny Jabbal, Mb Chb

  University of Dundee

  PRINCIPAL INVESTIGATOR

• Brian Lipworth, MD, Mb Chb

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 17, 2016
• Study Start: July 11, 2016
• Primary Completion: May 22, 2019
• Study Completion: May 22, 2019
• Last Updated: June 21, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)