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Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma (QVM149)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)

Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)

Treatment C: Placebo (morning dose) and placebo (evening dose)

About this trial

This is an interventional treatment trial for Asthma focused on measuring QVM149,, asthma,, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria:

Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose
On a stable regimen for at least 4 weeks prior to screening.
Pre-bronchodilator FEV1 ≥ 60 % and < 100% of the predicted normal value for the patient during screening.
Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening.
At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges:
oral body temperature between 35.0-37.5 °C
systolic blood pressure, 90-159 mmHg
diastolic blood pressure, 50-99 mmHg
pulse rate, 40-90 bpm
Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial.
Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2.

Exclusion Criteria:

Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class
Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening.
Patients who have had previous intubation for a severe asthma ttack/exacerbation.
Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers.
History of paradoxical bronchospasm in response to inhaled medicines.
Patients who during the run-in period prior to randomization require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEFof ≥ 30% for 6 consecutive scheduled PEF readings
Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Sites / Locations

Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site
Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

Patients will receive in a sequential order the following interventional treatments: A,B and C.

Patients will receive in a sequential order the following interventional treatments: B, A and C.

Patients will receive in a sequential order the following interventional treatments: C, B and A.

Patients will receive in a sequential order the following interventional treatments : C, A and B.

Patients will receive in a sequential order the following interventional treatments: A, C and B.

Patients will receive in a sequential order the following interventional treatments: B, C and A.

Outcomes

Primary Outcome Measures

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period

Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.

Secondary Outcome Measures

Trough FEV1 After 24h

FEV1 at approximately 24 h after the last p.m. or penultimate a.m. dose. Morning and evening trough FEV1 (L) were analyzed by time of day. For morning trough FEV1 (L) assessments this meant that the spirometric assessment was done approximately 24 h after last morning dose and approximately 12 h after last evening dose.

Peak Expiratory Flow (PEF)

Peak expiratory flow (PEF) is the maximum flow generated during a forceful exhalation, starting from full lung inflationDaily morning and evening peak expiratory flow rate from Day 2 to Day14 during the three treatment periods.

Full Information

NCT ID

NCT03108027

First Posted

March 23, 2017

Last Updated

December 9, 2020

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03108027

Brief Title

Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

Acronym

QVM149

Official Title

A Randomized, Double-blind, Repeat Dose Cross-over Study to Assess the Bronchodilator Effects of Once Daily QVM149 Following Morning or Evening Dosing for 14 Days Compared to Placebo in Patients With Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

June 26, 2017 (Actual)

Primary Completion Date

February 24, 2018 (Actual)

Study Completion Date

February 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

QVM149,, asthma,, allergic asthma,, allergy triggered asthma,, reactive asthma,, asthma attack,, difficulty breathing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Model Description

This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. It will provide evidence of the comparability of lung function effects of QVM149 irrespective of the administration schedule

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

This is a double-blind masking.

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence 1

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments: A,B and C.

Arm Title

Sequence 2

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments: B, A and C.

Arm Title

Sequence 3

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments: C, B and A.

Arm Title

Sequence 4

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments : C, A and B.

Arm Title

Sequence 5

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments: A, C and B.

Arm Title

Sequence 6

Arm Type

Experimental

Arm Description

Patients will receive in a sequential order the following interventional treatments: B, C and A.

Intervention Type

Drug

Intervention Name(s)

Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)

Intervention Description

Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)

Intervention Type

Drug

Intervention Name(s)

Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)

Intervention Description

QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)

Intervention Type

Drug

Intervention Name(s)

Treatment C: Placebo (morning dose) and placebo (evening dose)

Intervention Description

Placebo (morning dose) and placebo (evening dose)

Primary Outcome Measure Information:

Title

FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period

Description

Weighted mean forced expiratory volume in 1 second (FEV1) over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.

Time Frame

At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Secondary Outcome Measure Information:

Title

Trough FEV1 After 24h

Description

Time Frame

At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Title

Peak Expiratory Flow (PEF)

Description

Time Frame

From treatment period start through study completion (up to 19 weeks).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with a documented physician diagnosis of asthma and who additionally meet the following criteria: Patients receiving daily treatment with an inhaled corticosteroid at a low or medium daily dose On a stable regimen for at least 4 weeks prior to screening. Pre-bronchodilator FEV1 ≥ 60 % and < 100% of the predicted normal value for the patient during screening. Patients who demonstrate an increase in FEV1 of ≥ 12 % and ≥ 200 mL after administration of 400 μg salbutamol/360 μg albuterol (or equivalent dose) at Screening. All patients must perform a reversibility test at Screening. At screening, and baseline (day 1 pre-dose time) of the first treatment period, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position and again in the standing position as outlined in the SOM. Sitting and standing vital signs should be within the following ranges: oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-159 mmHg diastolic blood pressure, 50-99 mmHg pulse rate, 40-90 bpm Hypertensive patients must have been on stable antihypertensive therapy for at least 4 weeks prior to screening to be included in the trial. Patients must weigh at least 50 kg at screening to participate in the study, and must have a body mass index (BMI) within the range of 18 to 40 kg/m2. Exclusion Criteria: Contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the drugs of a similar class Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 1 year of Screening. Patients who have had previous intubation for a severe asthma ttack/exacerbation. Patients with a history of clinically relevant bronchoconstriction upon repeated forced expiratory maneuvers. History of paradoxical bronchospasm in response to inhaled medicines. Patients who during the run-in period prior to randomization require the use of ≥12 puffs / 24 hours of rescue medication for 48 hours (over two consecutive days) or who have a decline in PEF from the reference PEFof ≥ 30% for 6 consecutive scheduled PEF readings Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers).

Facility Information:

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt Am Main Hessen

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Grosshansdorf

ZIP/Postal Code

22947

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Wiesbaden

ZIP/Postal Code

65187

Country

Germany

Facility Name

Novartis Investigative Site

City

Groningen

State/Province

ZIP/Postal Code

9713

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Machester

ZIP/Postal Code

M23 9QZ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=413

Description

A Plain Language Trial Summary is available on novartisclinicatrials.com

Learn more about this trial

Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma

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