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

December 9, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
38

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Novartis Investigative Site
      • Frankfurt Am Main Hessen, Germany, 60596
        • Novartis Investigative Site
      • Grosshansdorf, Germany, 22947
        • Novartis Investigative Site
      • Hannover, Germany, 30625
        • Novartis Investigative Site
      • Wiesbaden, Germany, 65187
        • Novartis Investigative Site
  • Netherlands
    • GZ
      • Groningen, GZ, Netherlands, 9713
        • Novartis Investigative Site
  • United Kingdom
      • Machester, United Kingdom, M23 9QZ
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sequence 1
Patients will receive in a sequential order the following interventional treatments: A,B and C.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 2
Patients will receive in a sequential order the following interventional treatments: B, A and C.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 3
Patients will receive in a sequential order the following interventional treatments: C, B and A.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 4
Patients will receive in a sequential order the following interventional treatments : C, A and B.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 5
Patients will receive in a sequential order the following interventional treatments: A, C and B.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)
Experimental: Sequence 6
Patients will receive in a sequential order the following interventional treatments: B, C and A.
Drug: Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
Drug: Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
Drug: Treatment C: Placebo (morning dose) and placebo (evening dose)
Placebo (morning dose) and placebo (evening dose)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Time Frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
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.
At the end of each treatment period day 14 pre-dose to 24 hours post-dose.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trough FEV1 After 24h
Time Frame: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
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.
At the end of each treatment period day 14 pre-dose to 24 hours post-dose.
Peak Expiratory Flow (PEF)
Time Frame: From treatment period start through study completion (up to 19 weeks).
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.
From treatment period start through study completion (up to 19 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CQVM149B2209
  • 2017-000644-17 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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