Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3

NCT02322788 | Completed Phase 3 Results

• 1 other identifier: D4711C00001
• Study Type: interventional
• Target: 95
• Locations: 3 countries
• Sites: 4

Brief Summary

A randomised, double-blind, double-dummy, multi-site, phase III, single dose, 4-way cross-over pharmacodynamic study evaluating the efficacy of Bricanyl Turbuhaler M3 compared to Bricanyl Turbuhaler M2 by studying the protective effect on methacholine induced bronchoconstriction in patients with stable, mild to moderate asthma

Conditions

Asthma

Keywords

Inhalation, Pharmacodynamic, Patients,

Outcome Measures

Primary Outcomes (1)

• Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)

  4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods

Study Arms (4)

Bricanyl Turbuhaler M2, Active

ACTIVE COMPARATOR

Terbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation

Drug: Terbutaline sulphate

Bricanyl Turbuhaler M3, Active

ACTIVE COMPARATOR

Terbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation

Drug: Terbutaline sulphate

Turbuhaler M2, Placebo

PLACEBO COMPARATOR

Placebo powder for inhalation

Drug: Placebo for terbutaline sulphate

Turbuhaler M3, Placebo

PLACEBO COMPARATOR

Placebo powder for inhalation

Drug: Placebo for terbutaline sulphate

Interventions

Terbutaline sulphate DRUG

Bricanyl Turbuhaler M2

Also known as: Terbutaline sulphate powder for inhalation, 0.5 mg (metered dose) terbutaline per inhalation

Bricanyl Turbuhaler M2, Active

Placebo for terbutaline sulphate DRUG

Placebo Turbuhaler M2

Also known as: Placebo powder for inhalation

Turbuhaler M2, Placebo

Eligibility Criteria

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

You may qualify if:

• At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1
• Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide corresponding) or on fixed combination of low ICS/LABA
• At the enrolment visit 1a, the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III). For LABA patients the visit baseline FEV1 must be ≥80 % of that predicted normal (NHANES III) at both visit 1a and visit 1b. If not, the patient will be withdrawn from the study
• At the enrolment visits 1a or 1b (LABA patients only) and at the end of run-in period, visit 2, eligible patients should demonstrate an airway responsiveness to methacholine PC20 \<8 mg/mL. If not, the patient will be withdrawn from the study

You may not qualify if:

• Pregnancy, breast-feeding, lactation, or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures
• Conditions which could alter airway reactivity to methacholine (e.g. pneumonia, upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within past six weeks
• Exacerbation due to asthma or change in asthma medication during the last 3 months prior to enrolment
• Night time awakenings due to asthma symptoms on 2 consecutive nights during the last 4 weeks prior to enrolment
• Smokers 6 months prior to the study start or with a history of smoking of more than 10 pack years (e.g. 20 cigarettes/day for at least 10 years, or 10 cigarettes/day for at least 20 years, or equal).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (4)

Research Site

Hamilton, Ontario, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Groningen, Netherlands

Location

Research Site

Lund, Sweden

Location

Related Publications (1)

• Bjermer L, Gauvreau GM, Postma DS, O'Byrne PM, van den Berge M, Boulet LP, Beckman O, Persson T, Roman J, Carlholm M, Schutzer KM, Eckerwall G. Methacholine challenge tests to demonstrate therapeutic equivalence of terbutaline sulfate via different Turbuhaler(R) devices in patients with mild to moderate asthma: Appraisal of a four-way crossover design. Pulm Pharmacol Ther. 2017 Jun;44:1-6. doi: 10.1016/j.pupt.2017.02.004. Epub 2017 Feb 20.

  PMID: 28232118 DERIVED

MeSH Terms

Conditions

Asthma; Respiratory Aspiration

Interventions

Terbutaline; Inhalation

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Göran Eckerwall, MD, PhD
• Organization: AstraZeneca R&D Gothenburg, SE-431 83 Mölndal, Sweden

goran.eckerwall@astrazeneca.com

+46 708467664

Study Officials

• Göran Eckerwall, MD

  AstraZeneca Mölndal, Sweden

  STUDY DIRECTOR

• Leif Bjermer, MD, Professor

  Skånes University hospital, Lund

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 23, 2014
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 13, 2017
• Results First Posted: November 7, 2016

Record last verified: 2016-11

Locations

NL (1); SE (1); CA (2)