Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 6 for:    QVM149

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108027
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : May 21, 2019
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Treatment A: 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) Drug: Treatment C: Placebo (morning dose) and placebo (evening dose) Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This is a double-blind masking.
Primary Purpose: Treatment
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
Actual Study Start Date : June 26, 2017
Actual Primary Completion Date : February 24, 2018
Actual Study Completion Date : February 24, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108027


Locations
Layout table for location information
Germany
Novartis Investigative Site
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
Netherlands
Novartis Investigative Site
Groningen, GZ, Netherlands, 9713
United Kingdom
Novartis Investigative Site
Machester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] March 27, 2018
Study Protocol  [PDF] March 8, 2017


Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03108027     History of Changes
Other Study ID Numbers: CQVM149B2209
2017-000644-17 ( EudraCT Number )
First Posted: April 11, 2017    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: May 21, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QVM149,
asthma,
allergic asthma,
allergy triggered asthma,
reactive asthma,
asthma attack,
difficulty breathing
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents